louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04814277: Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure
Official title: Accuracy Evaluation for Software-based Visualization of GPi/GPe Anatomical Brain Structure Using Surgical Information Sciences Inc. Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Software Evaluation for Visualizing Anatomical Structures Not Typically Identified on Clinical MR Images
Lead sponsor: Surgical Information Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cohort of 34 adults who will be scanned on a 3T and 7T MRI to obtain anatomical images of their brain.

Brief summary: SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.

Detailed description: A cohort of 34 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (7T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images.

SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images in the same subject obtained from the 7T MRI.

Eligibility criteria: Inclusion Criteria:

* All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.

Exclusion Criteria:

1. MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g,. heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.
2. Pregnant women.
3. Subject under the age of 18.

Primary outcomes:
measure: Validation of the accurate visualization of brain structure based on SIS algorithms - 1
timeFrame: Through study completion, up to 1 year
measure: Validation of the accurate visualization of brain structure based on SIS algorithms - 2
timeFrame: Through study completion, up to 1 year
measure: Validation of the accurate visualization of brain structure based on SIS algorithms - 3
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Surgical Information Sciences
state: Minnesota
Study officials:
References:
Clinical trial NCT02055677: Personality Profiles, Values and Empathy: Differences Between Ovo/Lacto-vegetarians and Vegans
Official title: Personality Profiles, Values and Empathy: Differences Between Ovo/Lacto-vegetarians and Vegans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Personality
Keywords: personality profiles
values
empathy
quality of life
vegetarians
vegans
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Universität Duisburg-Essen
First posted: 2014-02-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5000-10000 vegetarian volunteers

Brief summary: Main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and vegans with respect to their personality profiles, values and empathy through validated questionnaires. Main hypothesis: vegans and ovo / lacto-vegetarians differ in their personality, empathy and values


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years of age

Exclusion Criteria:

* Age under 18 and above 80 years of age

Primary outcomes:
measure: Big Five SOEP Inventory
timeFrame: Once at baseline
Secondary outcomes:
measure: Other Validated Questionnaires
timeFrame: Once at baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Medical University, Germany
Study officials:
affiliation: Charité Medical University, Germany
name: Andreas Michalsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kessler CS, Michalsen A, Holler S, Murthy VS, Cramer H. How empathic are vegan medical professionals compared to others? Leads from a paper-pencil-survey. Eur J Clin Nutr. 2018 May;72(5):780-784. doi: 10.1038/s41430-017-0007-8. Epub 2017 Nov 6.
Clinical trial NCT06437847: Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors
Official title: Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Disorder
Keywords: Cognitive evaluation
Short Test
General Practitioners
Codex, Training
Formation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General practitioners of the AURA Region will be included.

Brief summary: The prevalence of cognitive disorders is constantly increasing, with 1.2 million patients affected in France in 2016. Dementia is currently the seventh leading cause of death. In the absence of available treatment, systematic screening is not recommended. However, cognitive evaluation is recommended to maintain a level of autonomy for the patient at home. Targeted screening is the responsibility of the general practitioner. The latest recommendations from the HAS (2011) highlight the use of the MMSE as a first-line approach, there are no recommendations regarding short tests. Early cognitive assessment is limited by the time required to perform the tests and the knowledge about the available tools. The Codex is a short test, its sensitivity (92%) and specificity (85%) place it among the most discriminatory scores. It is underutilized in France. The objective of this thesis is to assess the training needs of general practitioners in short tests.


Eligibility criteria: Inclusion Criteria:

* General practitioners of the AURA Region, in activity, university supervisor or not, trained or not trained in geriatrics.

Exclusion Criteria:

* General practitioners with exclusive practices in pediatrics, gynecology, aesthetics, rehabilitation, and homeopathy.

Primary outcomes:
measure: Quantitative questionnaire 1
timeFrame: Month : 1, 3, 6
Secondary outcomes:
measure: Quantitative questionnaire 2
timeFrame: Month : 1, 3, 6
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de Saint-Etienne
Study officials:
References:
Clinical trial NCT00555347: Use of Armodafinil for Fatigue in Sarcoidosis
Official title: Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sarcoidosis
Fatigue
Sleepiness
Keywords: Sarcoidosis
Fatigue
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Cephalon
First posted: 2007-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

Detailed description: The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment.

Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life.

They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of sarcoidosis using standard criteria 15.
* Disease for more than one year
* On stable, systemic therapy
* Complain of fatigue which has been present for more than six months.
* Over 18 years of age
* Provide written informed consent.

Exclusion Criteria:

* Pregnancy
* Change in therapy for sarcoidosis in prior three months
* History of ventricular arrythmias

Primary outcomes:
measure: To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
timeFrame: Prospective
Secondary outcomes:
measure: To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.
timeFrame: Prospective
measure: To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.
timeFrame: Prospective
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert P Baughman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02419547: Inducibility and Stability of Ventricular Tachycardia Inpatients Undergoing VT Ablation Under General Anesthesia
Official title: Inducibility and Stability of Ventricular Tachycardia in Patients With Structural Heart Disease Undergoing VT Ablation Under General Anesthesia (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Ventricular tachycardia
ventricular tachycardia ablation
effects of anesthesia on VT induction
programed stimulation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 11
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: This research study is being done to see whether general anesthesia (GA) affects our ability to start ventricular tachycardia (VT) during an VT ablation procedure.

Data collected during this research study will help electrophysiologists and anesthesiologists to make the best decisions about the best anesthetic conditions to use to perform VT ablations.

This research study is a "pilot" study. Pilot studies are done on a small group of subjects to learn if a larger study would be useful.


Eligibility criteria: Inclusion Criteria:

* Patients with VT and have an implanted ICD who are scheduled for VT catheter ablation.
* Patients 18 years of age or older

Exclusion Criteria:

* Patients with difficult airway management or patients with contra/ relative contra indication for general anesthesia or known allergies to any of the proposed anesthetic agents
* Women who are pregnant

Primary outcomes:
measure: Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.
timeFrame: While under General Anesthesia, an average of 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigahm and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Wendy L Gross, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04096547: Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Official title: A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Rivaroxaban
Elderly
Renal Insufficiency
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2019-09-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients,

Brief summary: Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea

This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients.

Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban

Detailed description: Study Population Elderly patients with age ≥ 65 years with treatment naïve or treatment-experienced patients who are diagnosed with NVAF Expected number of patient enrollment is about 1200 patients, Samsung Medical Center is aim to enroll about 200 patients

Eligibility criteria: Inclusion Criteria:

1. Patients with consent given
2. Elderly patients with age 65 ≥ years old
3. NVAF patients first time prescription to rivaroxaban or patients who started rivaroxaban treatment within 3 months

Exclusion Criteria:

1. Refusal to participate in this study or to give an informed consent
2. Patients with moderate to severe mitral stenosis
3. Patients with mechanical valve
4. Contraindication from rivaroxaban Korea SmPC

Primary outcomes:
measure: Composite incidence of stroke/ non-CNS SE
timeFrame: 1 year
Secondary outcomes:
measure: Bleeding incidence
timeFrame: 1 year
Other outcomes:
measure: renal function
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT03546647: Toric Contact Lens Performance Study
Official title: Toric Contact Lens Performance Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Detailed description: This is a prospective, single site, randomized, masked, crossover study. This study will evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and improve digital reading performance. Symptoms and objective near vision outcomes will be measured at baseline and after 1 week of wear with each correction.

Eligibility criteria: Inclusion

+6.00 to -6.00 D vertexed sphere power and -0.75 to -1.50 D vertexed refractive cylinder in the right and left eyes Best corrected acuity of 20/25 or better in each eye Self report of at least 4 hrs/day using digital devices Current/established soft contact lens wearer (has worn contact lenses in the past year)

Exclusion An optometrist or optometry student History of ocular pathology or surgery Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency) Gas permeable lens wear for at least 3 months Presbyopic (based on refraction)

Primary outcomes:
measure: Near Visual LogMAR Acuity
timeFrame: 10 +/- 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
affiliation: University of Houston College of Optometry
name: Kathryn Richdale, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04591847: Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy
Official title: Pregnancy Outcomes and Vitamin D Level Among Vitamin D Supplementation During Pregnancy : A Double-blind Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy
Keywords: Vitamin D
25-hydroxyvitamin D
Pregnancy
Infant
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-10-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant women who were given vitamin D supplementation and pregnant women who were given placebo


Eligibility criteria: Inclusion Criteria:

* Thai female
* Singleton pregnancy
* Age at 18 years old or more
* Gestational age at 18-22 weeks
* Accept to enroll

Exclusion Criteria:

* Pregnant women who not planned to delivery at Rajavithi hospital
* Abnormal kidney function
* Use antiepileptic drugs , or vitamin D supplementation
* Allergy to vitamin D
* Who were diagnosed as vitamin D deficiency

Primary outcomes:
measure: Serum 25-OH vitamin D level in pregnant women
timeFrame: At delivery time
measure: Serum 25-OH vitamin D level in umbilicalcord blood
timeFrame: At delivery time
Secondary outcomes:
measure: Preeclampsia
timeFrame: During pregnancy until delivery
measure: Preterm birth
timeFrame: At delivery time
measure: Infant APGAR score
timeFrame: At delivery time
measure: Infant birth weight
timeFrame: At delivery time
measure: Infant length
timeFrame: At delivery time
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
References:
Clinical trial NCT00799747: Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.
Official title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study in Healthy Japanese Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD4017 After Single Ascending Oral Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
pharmacokinetics
AZD4017Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Provision of signed written and dated informed consent
* BMI between 19 and 27 kg/m2
* Subjects must be willing to use barrier methods of contraception

Exclusion Criteria:

* History of any clinical significant disease
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).

Primary outcomes:
measure: Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables
timeFrame: The variables will be measure predose and the repeatedly during the following 47 hours after dosing
Secondary outcomes:
measure: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F)
timeFrame: Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: Kyusyu Clinical Phramacology Research Clinic
name: Shunji Matsuki
role: PRINCIPAL_INVESTIGATOR
References: