louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05797779: Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease
Official title: Molecular Characterization of Induced Neuronal Cells Derived From Fibroblasts of Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18 years or older
2. Patients with Parkinson's disease, according to the most recent diagnostic criteria
3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders
2. Patients with neurological diseases other than Parkinson's disease
3. Inability to sign an informed consent
4. Severe psychiatric diseases

Primary outcomes:
measure: Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinson's disease.
timeFrame: Baseline
measure: Biochemical characterization of dopaminergic neurons derived from patients with Parkinson's disease.
timeFrame: Baseline
measure: α-synuclein misfolding in dopaminergic neurons derived from patients with Parkinson's disease.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Flavia Torlizzi
Study officials:
References:
Clinical trial NCT05332379: Regional Hemodynamic Parameter Changes After Spinal Anesthesia
Official title: Measurement of Regional Hemodynamic Parameters Before and After Spinal Anesthesia with Doppler USG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia Evaluation
Keywords: Spinal anesthesia
Test
Pulsed Wave Doppler
Sympathectomy
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective operation with spinal anesthesia will be recruited for the study. Posterior tibial artery velocities (peak systolic, end-diastolic) and the vessel diameters will be measured via USG Pulsed Wave Doppler mode. Three measurements will be performed: before spinal anesthesia, at the 5th and at the 10th minutes after the subarachnoid injection. The patients' sensory and motor examinations will be performed as well.

Brief summary: Spinal anesthesia is a regional anesthesia method used for surgical procedures generally involving the lower abdominal area, perineum, and lower extremities. Various tests are performed to evaluate the block level after spinal anesthesia, incluyding pinprick test, cold application, and motor examination. These tests are performed to check whether the pain, sympathetic and motor nerve fibers are affected, respectively, after the block; and good communication with the patient is important here. However, it is extremely difficult to evaluate these tests in pediatric, geriatric, mentally retarded or uncooperative patients.

Sympathectomy can be used as a criterion to evaluate the success of the block that occurs after the spinal anesthesia procedure. Sympathetic nerve fibers are the first to be affected by the block, and the success of the block can be evaluated with the revealed sympathectomy. Sympathectomy in the lower extremities after spinal block increases arterial blood flow. This increase in blood flow can be detected by the Pulsed Wave Doppler feature of USG.


Eligibility criteria: Inclusion Criteria:

* Elective surgery under spinal anesthesia
* American Society of Anesthesiologists (ASA) I-II physical status

Exclusion Criteria:

* Contraindication for spinal anesthesia
* ASA physical status \>II
* Vasoactive drug usage

Primary outcomes:
measure: Arterial velocity changes
timeFrame: At the 5th and 10th minutes after the spinal anesthesia procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Pendik
Study officials:
References:
Clinical trial NCT06660979: Using Reinforcement Learning to Personalize Electronic Health Record Tools to Facilitate Deprescribing
Official title: Using Reinforcement Learning to Personalize Electronic Health Record Tools to Facilitate Deprescribing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Keywords: Medication optimization
High-risk medications
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Atrius Health
First posted: 2024-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall goal of the proposed research is to refine and adapt and perform efficacy testing of a novel reinforcement learning-based approach to personalizing EHR-based tools for PCPs on deprescribing of high-risk medications for older adults. The trial will be conducted at Atrius Health, an integrated delivery network in Massachusetts, and will intervene upon primary care providers. The investigators will conduct a cluster randomized trial using reinforcement learning to adapt electronic health record (EHR) tools for deprescribing high-risk medications versus usual care. 60 PCPs will be randomized (i.e., 30 each to the reinforcement learning intervention and usual care \[no EHR tool\] in each arm) to the trial and follow them for approximately 30 weeks. The primary outcome will be discontinuation or ordering a dose taper for the high-risk medications for eligible patients by included primary care providers, using EHR data at Atrius. The primary hypothesis is that the personalized intervention using reinforcement learning will improve deprescribing compared with usual care.


Eligibility criteria: Inclusion Criteria:

The trial will intervene upon primary care providers (including physicians and PCP-designated nurse practitioners and physician assistants) at Atrius Health.

Patients of the PCPs will be included in the intervention and analysis if they are \>/=65 years of age and have been prescribed \>/= 90 pills of high-risk medications in the prior 180 days based on EHR data.

Exclusion Criteria:

* Not a primary care provider at Atrius Health
* Prior randomization to intervention arm in the prior NUDGE-EHR trial

Primary outcomes:
measure: Discontinuation or taper for high-risk medication
timeFrame: Through trial completion, up to 7 months
Secondary outcomes:
measure: Discontinuation of high-risk medication
timeFrame: Through trial completion, up to 7 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Atrius Health
state: Massachusetts
Study officials:
References:
Clinical trial NCT04660279: Dynamic FDG PET/CT: Optimization and Validation of Data Acquisition
Official title: Dynamic Wholebody FDG PET/CT - Next Generational Functional Imaging: Optimization and Validation of Data Acquisition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positron-Emission Tomography
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Quantification of the metabolic rate of glucose from Dynamic Whole-Body PET examinations requires measurements of the time course of the radioactivity concentrations in arterial blood by blood sampling, and in the tissue of interest by dynamic PET. Invasive arterial blood sampling cannot be part of a standard examination, and therefore the blood samples need to be replaced by activity concentrations derived from the PET images, usually from small volumes in the descending aorta or left ventricle.

Newly developed scanner software (Siemens) allows automated CT-based identification of blood pool regions and extraction of an image-derived blood input function from the corresponding PET data.

However, this automated method needs validation, as it could be prone to systematic errors caused by limited spatial resolution, patient movement, and image reconstruction. We will use invasively measured arterial blood samples as a reference for validation of methods to extract non-invasive PET image-derived input functions and quantify any systematic errors that could propagate to the resulting parametric images.


Eligibility criteria: Inclusion Criteria:

* Patients with a planned clinical standard PET/CT as part of pre-therapeutic staging, response assessment scanning.
* Good performance status, which will allow us to obtain informed consent to draw the required arterial blood samples during the examination, and which will permit patients to lay still in the scanner for at least 70 min.

Exclusion Criteria:

* • Age \< 18 or \> 85 years

  * Patients that can not tolerate a PET scan (f.ex: claustrophobia).

Primary outcomes:
measure: Validation of current parametric reconstruction protocol
timeFrame: through study completion, an average of 1 year
measure: Time reduction of current parametric reconstruction protocol
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT00987779: Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Official title: An Open, Randomized, Crossover Study In Healthy Subjects To Assess The Bioequivalence Of Gabapentin Between Japanese Commercial Tablet And Japanese Commercial Image Liquid Formulation And The Effect Of Food On The Pharmacokinetics Of Japanese Commercial Image Liquid Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence study
Food effect study
Pharmacokinetics
Gabapentin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation. Secondary objective for this study is to estimate the food effect for Japanese commercial image liquid formulation.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Primary outcomes:
measure: Pharmacokinetic (PK) Endpoints - Primary: plasma Cmax and AUCt of gabapentin. - Secondary: plasma AUCinf, AUClast, Tmax, kel, MRT and t1/2 of gabapentin
timeFrame: dosing to 3 days
Secondary outcomes:
measure: Safety Endpoints - Adverse events and safety laboratory data
timeFrame: dosing to 3 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05658679: Radiomics in Pancreatic Cancer
Official title: Radiomics-based Detection and Outcome Prediction for Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants willing to receive abdominal imaging could be included in this study

Brief summary: The images of patients with pancreatic cancer were collected and analyzed based on the methodes of radiomics


Eligibility criteria: Inclusion Criteria:

* Gender unlimited, 18-80 years old;
* Received abdominal imaging;
* informed consent signed.

Exclusion Criteria:

* Pregnant / lactating women；
* Contraindications of imaging examination。

Primary outcomes:
measure: 5-year survival rate
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01135979: Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure
Official title: Assessment of the Sympathetic Nervous System Blockade of the Upper Limb After a Brachial Plexus Block in Patients With End Stage Renal Failure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Failure
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 0
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: Patients with end stage renal failure who are due to have a forearm fistula created

Brief summary: The purpose of this study is to investigate what effect a local anesthetic nerve block of the arm in patients with end stage renal failure has upon blood flow in the skin of the arm.

Detailed description: Aim

To quantify the degree of sympathetic blockade in the upper limb in patients with end stage renal failure produced during a regional anaesthetic technique, using laser Doppler flowmetry.

Hypothesis

Regional anaesthesia of the upper limb results in blockade of motor and sensory nerves, providing surgical and post-operative analgesia. Sympathetic nerves are also blocked resulting in local vasodilatation. This may be of benefit in surgery where enhanced blood flow is beneficial such as arterio-venous fistula creation. The degree and duration of sympathetic blockade produced by regional blocks however, has never been quantified. This study aims to quantify sympathetic blockade by measuring the changes in skin blood flow and skin temperature after placement of a brachial plexus block.

Eligibility criteria: Inclusion Criteria:

* Patients with end stage renal failure
* Over 18 years of age
* Written consent obtained
* Due to undergo surgery for forearm fistula creation under a regional block

Exclusion Criteria:

* Smokers
* Damaged skin on the arm
* Circulatory disorders such as Raynaud's disease, systemic sclerosis, sickle cell trait or disease
* Current use of beta blockers
* undergoing haemodialysis for more than 12 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
References:
Clinical trial NCT03544879: Yoga to Prevent Mobility Limitations in Older Adults
Official title: Yoga to Prevent Mobility Limitations in Older Adults: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Mobility Limitation
Sedentary Lifestyle
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 46
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. The study objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations. The investigators hypothesized that sedentary older adults could be recruited for the study, would attend either yoga or a health education control, would complete assessments, and that the interventions could be safely delivered.


Eligibility criteria: Inclusion Criteria:

* age 60-89 years
* self-reported sedentary lifestyle (not exercising in the past 3 months; included walking at a brisk pace or regular walking for exercise purposes)
* SPPB summary score \> 3 and ≤ 8
* willingness attend either yoga or health education for 10 weeks
* willing to complete two assessments
* residence in San Diego metropolitan area
* provided a physician-signed health clearance form.

Exclusion Criteria:

* practiced yoga \> 2x in the last year
* life expectancy \< 12 months.

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change in SPPB from baseline to 10 weeks
Secondary outcomes:
measure: Step Up and Over (SUO)
timeFrame: Change from baseline to 10 weeks
measure: Rhythmic Weight Shift (RWS)
timeFrame: Change from baseline to 10 weeks
measure: Sensory Organization Test (SOT) Vestibular
timeFrame: Change from baseline to 10 weeks
measure: Limits of Stability (LOS)
timeFrame: Change from baseline to 10 weeks
measure: Grip Strength
timeFrame: Change from baseline to 10 weeks
measure: SF-36
timeFrame: Change from baseline to 10 weeks
measure: Center for Epidemiologic Studies Short Depression Scale (CES-D 10)
timeFrame: Change from baseline to 10 weeks
measure: Brief Anxiety Inventory (BAI)
timeFrame: Change from baseline to 10 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline to 10 weeks
measure: Participant Satisfaction
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Groessl EJ, Maiya M, Schmalzl L, Wing D, Jeste DV. Yoga to prevent mobility limitations in older adults: feasibility of a randomized controlled trial. BMC Geriatr. 2018 Dec 12;18(1):306. doi: 10.1186/s12877-018-0988-8.
Clinical trial NCT05858879: Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
Official title: Notification of Incidental Coronary Artery Calcium in Patients With Atherosclerotic Cardiovascular Disease (NOTIFY-ASCVD)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: ASCVD
Coronary Artery Calcification
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.
Primary purpose: PREVENTION

Brief summary: Estimate the impact of notifying both patients and their clinicians of the presence of incidental coronary artery calcium (CAC) on initiation of lipid-lowering therapy in patients with ASCVD who are not receiving lipid-lowering therapy.

Detailed description: This is a randomized quality improvement (QI) project evaluating the impact of notifying patients and their clinicians (primary care, cardiologists, neurologists, or vascular surgeon) of incidental CAC detected on a prior chest CT scan. Patients will be identified by screening previous non-gated chest CT scans and electronic health records. The presence of CAC will be confirmed by a radiologist. Eligible patients will be randomized to: 1) notification of presence of CAC with a CT scan image; 2) notification of presence of CAC without a CT scan image; 3) or usual care.

Eligibility criteria: Inclusion Criteria:

1. Presence of CAC on non-gated chest CT scans performed from 2021 to 2023
2. Age \<85 years
3. Diagnosis of coronary artery disease, peripheral artery disease, or cerebrovascular disease
4. Visit to Stanford affiliated clinician since 2021 at one of the following Stanford clinics including University affiliated clinics:

   1. Internal Medicine
   2. Family Medicine
   3. Cardiology
   4. Neurology
   5. Vascular surgery

Exclusion Criteria:

1. No diagnosis of ASCVD
2. Patients receiving lipid-lowering therapy
3. Dementia
4. Metastatic cancer or active cancer undergoing chemotherapy

Primary outcomes:
measure: Initiation of lipid-lowering therapy
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT06289179: Thyroid and Cortisol Hormone Response to Sepsis
Official title: Thyroid and Cortisol Hormone Response in Patients With Sepsis Who Attended To Assiut University Hospitals (ICU)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sepsis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: include Adults (≥18 years), both genders, admitted to critical care unit with sepsis

Exclusion patient with Previous diagnosis of endocrinal changes (thyroid dysfunction , hypopituitarism, Addison disease, Cushing syndrome)

Brief summary: Thyroid and cortisol hormone response to sepsis

Detailed description: Sepsis is dysregulated host response to infection that results in life-threatening organ dysfunction. Virtually every body system can be affected by this syndrome to greater or lesser extents.

Endocrine alterations are well characterised in sepsis with variations in circulating blood levels and/or receptor resistance.

In response to any psychological or physical stressor, there is widespread neurohormonal activation to adapt body with the stressor. Production and secretion of stress hormones increase to modulate behaviour Many studies have been performed investigating specific hormonal perturbations such as critical illness-induced corticosteroid insufficiency ,all of which are associated with worse outcomes and poor of body inflammation. However, the endocrine system as a whole has been largely overlooked as a fundamental contributor to the integrated host response to sepsis thyroid axis is affected during sepsis with decreased pituitary release of thyroid stimulating hormone (TSH) and inhibition of the peripheral conversion of thyroxine (T4) by 5-deiodinase to the much more metabolically active triiodothyronine (T3). High cortisol levels also inhibit this enzymatic conversion.

Eligibility criteria: Inclusion Criteria:

* The study will include Adults (≥18 years), both genders
* septic patients admitted to critical care unit

Exclusion Criteria:

* thyroid disease
* hypopituitarism
* Addison disease
* Cushing syndrome)

Primary outcomes:
measure: Pattern of cortisol level and thyroid function response to sepsis in ICU
timeFrame: From time of admission to ICU up to 3rd day after discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Silva MH, Araujo MC, Diniz EM, Ceccon ME, Carvalho WB. Thyroid abnormalities in term infants with fungal sepsis. Rev Assoc Med Bras (1992). 2016 Sep;62(6):561-567. doi: 10.1590/1806-9282.62.06.561.