louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02677454: Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Official title: Evaluation of a Flash Glucose Monitoring System in Ambulatory Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus
Keywords: Blood Glucose
Blood Glucose Self-Monitoring
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2016-02-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the accuracy of the Flash Glucose Monitoring system (FGM), Abbot FreeStyle Libre, used today in clinical practice in Sweden in estimating plasma glucose levels. Data will be collected in ambulatory patients with type 1 diabetes to determine safety, accuracy, and reliability.


Eligibility criteria: Inclusion Criteria:

1. Type 1 diabetes
2. Adult patients, age 18 or older and \< 75 years
3. Written informed consent -

Exclusion Criteria:

1. Pregnancy
2. Patients with severe cognitive dysfunction or other disease which makes FGM use difficult
3. History of allergic reaction to any of the FGMs materials or adhesives in Contact with the skin.
4. History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
5. Continous Glucose Monitor (CGM) or FGM usage in the last month
6. Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)

   -

Primary outcomes:
measure: Mean Absolute Relative Difference (MARD)
timeFrame: the whole study period, day 1-14
Secondary outcomes:
measure: Mean absolute Difference (MAD)
timeFrame: the whole study period, day 1-14
measure: Pearson Correlation Coefficient
timeFrame: the whole study period, day 1-14
measure: Mean absolute relative difference (MARD)
timeFrame: the whole study period, day 1-14
measure: Mean absolute difference MAD
timeFrame: the whole study period, day 1-14
measure: Pearson Correlation
timeFrame: the whole study period, day 1-14
measure: Mean absolute relative difference (MARD)
timeFrame: the whole study period, day 1-14
measure: Mean absolute difference (MAD)
timeFrame: the whole study period, day 1-14
measure: Pearson Correlation
timeFrame: the whole study period, day 1-14
measure: questionnaire
timeFrame: the whole study period, day 1-14
Other outcomes:
Locations:
city: Uddevalla
country: Sweden
facility: NU-Hospital Group
Study officials:
affiliation: NU-Hospital Organization, Sweden
name: Marcus Lind, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05693454: Local Wound Anesthesia in Spine Surgery
Official title: Local Wound Anesthesia in Spine Surgery - a Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound
Orthopedic Disorder of Spine
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double blind, controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective, randomized, double-blinded, trial regarding the effect of local wound infiltration at the end of spine surgery; randomizing 1:1:1 between NaCl, Ropivacain, Levobupivacaine combined with Tramadol

Detailed description: Subcutaneous local wound injections with NaCl, Ropivacain or Levobupivacaine combined with Tramadol will be performed in a randomized, double-blinded manner at the end of spine surgery. Pain control, dosage of analgesics used, analgesics reduction compared to preoperative, wound healing problems and clinical outcome socres will be assessed up to 6 weeks after surgery

Eligibility criteria: Inclusion Criteria:

* Informed Consent
* Age ≥ 18 years
* Elective spine surgery with any technique
* At least 6 weeks of scheduled follow-up from hospitalization

Exclusion Criteria:

* Documented decline for data inclusion
* Allergy to any of the drugs used
* \<50kg total body weight
* Vertebro- or Kyphoplasty
* Pregnancy and breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Primary outcomes:
measure: Pain control
timeFrame: 2 hours after surgery
measure: Pain control
timeFrame: 4 hours after surgery
measure: Pain control
timeFrame: 8 hours after surgery
measure: Pain control
timeFrame: 12 hours after surgery
measure: Pain control
timeFrame: until 42 days after surgery
Secondary outcomes:
measure: costs
timeFrame: at 42 days after surgery
measure: sick leave
timeFrame: at 42 days after surgery
measure: hospital stay
timeFrame: up to 8 weeks
measure: wound drying
timeFrame: up to 8 weeks
measure: wound length
timeFrame: up to 8 weeks
measure: wound healing
timeFrame: until 42 days after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Mazda Farshad, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536354: Postural Orientation In The Use Of School Backpacks
Official title: Effects Of Postural Orientation In The Use Of School Backpacks In Elementary School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Backpain
Prevention
Physical Therapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2007-09-27
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will examine the effects of postural orientation in the use of school backpacks among elementary school students.


Eligibility criteria: Inclusion Criteria:

* Children from seven to ten years of age. Studing in private elementary school.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Susi MS Fernandes, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02763254: Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Official title: A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Lymphoma, Large B-Cell, Diffuse
Post-transplant Lymphoproliferative Disorder
Keywords: Epstein-Barr Virus
DLBCL
PTLD
EBV
CIVIC
HL
T cell
Lead sponsor: Cell Medica Ltd
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 1
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.


Eligibility criteria: Inclusion Criteria:

1. The study will include three primary cohorts, with any of the following EBV+ diseases:

   Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.

   Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.

   Cohort C - PTLD, rituximab treatment failure.
2. Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
3. Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
4. Absolute lymphocyte count (ALC) \>500/µL
5. Male or female ≥ 12 years of age
6. Weight ≥ 35 kg
7. Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
8. Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.

Exclusion Criteria:

1. Known central nervous system (CNS) lymphoma
2. Primary refractory HL or DLBCL
3. Bulky disease
4. Relapse or progression following previous autologous EBV specific T cell treatment.
5. Use of systemic corticosteroids \> 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
6. Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
7. Patient is pregnant or lactating
8. Systemic fungal, bacterial, viral or other infection that is not controlled
9. Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
10. Known history of primary immunodeficiency

Primary outcomes:
measure: Best Overall Response
timeFrame: 1 year
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cell Medica, Inc
name: Kurt Gunter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02785354: Anticoagulants Comparative Benefit-risk Ratio in Real Life
Official title: Engel 2: REal-life aNticoaGulants Comparative bEnefit-risk in Nonvalvular Atrial fibrilLation (NVAF) in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 103101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New users of NOAC or VKA for NVAF

Brief summary: The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.

The aim is to compare the one-year, two-year and three-year benefit-risk (major bleeding, arterial thrombotic events, myocardial infarction (MI), death) between patients starting a NOAC and patients starting a VKA for NVAF in 2013


Eligibility criteria: Inclusion criteria:

Patients with NVAF with a first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA in 2013, with no other identified indication for anticoagulation; Without any VKA or NOAC (Pradaxa®, Xarelto®, or Eliquis®) reimbursed dispensation for the last 3 years before the first reimbursed dispensation of Pradaxa®, Xarelto®, or VKA

Exclusion criteria:

None

Primary outcomes:
measure: Clinically Relevant Bleeding
timeFrame: One year
measure: Major Bleeding
timeFrame: 1 year
measure: Arterial Thrombotic Event
timeFrame: 1 year
measure: Acute Coronary Syndrome
timeFrame: One year
measure: Death (All-cause)
timeFrame: 1 year
measure: Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: 1160.263.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Blin P, Dureau-Pournin C, Benichou J, Cottin Y, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Real-Life Effectiveness and Safety of Dabigatran or Rivaroxaban vs. Vitamin K Antagonists: A High-Dimensional Propensity Score Matched New Users Cohort Study in the French National Healthcare Data System SNDS. Am J Cardiovasc Drugs. 2020 Feb;20(1):81-103. doi: 10.1007/s40256-019-00359-z.
citation: Blin P, Dureau-Pournin C, Cottin Y, Benichou J, Mismetti P, Abouelfath A, Lassalle R, Droz C, Moore N. Comparative Effectiveness and Safety of Standard or Reduced Dose Dabigatran vs. Rivaroxaban in Nonvalvular Atrial Fibrillation. Clin Pharmacol Ther. 2019 Jun;105(6):1439-1455. doi: 10.1002/cpt.1318. Epub 2019 Feb 6.
Clinical trial NCT01942954: Health Mobile Cognitive Stimulation in Alcohol Use Disorder
Official title: Executive Functioning in Patients With Alcohol Use Disorder Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol-Induced Disorders, Nervous System
Alcohol Dependence
Keywords: Alcohol Dependence
Cognitive Therapy
Executive Function
Mobile Health
Recovery of Function
Rehabilitation
Lead sponsor: Universidade Lusófona de Humanidades e Tecnologias
Sponsor class: OTHER
Collaborators: name: Universidade Lusófona de Humanidades e Tecnologias
First posted: 2013-09-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The consequences of alcohol dependence are severe and may range from physical diseases to neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex. To assess these deficits and the application of a novel approach of cognitive stimulation to alcoholics, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in a three-day/week basis.


Eligibility criteria: Inclusion Criteria:

Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised were included in the study.

Exclusion Criteria:

Patients with dependency from substances other than alcohol or with history of previous neurological disorders were excluded from the study. Patients were also screened for minimal computer literacy; no patients were excluded due to lack of this criterion.

Primary outcomes:
measure: Change in the results of Frontal Assessment Battery - FAB
timeFrame: Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Sintra
country: Portugal
facility: Ares do Pinhal. Associação de Recuperação de Toxicodependentes
state: Lisboa
Study officials:
affiliation: Universidade Lusófona de Humanidades e Tecnologias
name: Pedro SP Gamito, PhD
role: STUDY_CHAIR
affiliation: Universidade Lusófona de Humanidades e Tecnologias
name: Jorge AG Oliveira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Lusófona de Humanidades e Tecnologias
name: Paulo JF Lopes, PhD
role: STUDY_DIRECTOR
References:
citation: Gamito P, Oliveira J, Lopes P, Brito R, Morais D, Silva D, Silva A, Rebelo S, Bastos M, Deus A. Executive functioning in alcoholics following an mHealth cognitive stimulation program: randomized controlled trial. J Med Internet Res. 2014 Apr 17;16(4):e102. doi: 10.2196/jmir.2923.
Clinical trial NCT03762954: Assessment of Cognitive and Functional Impairment in Older Patients After ERCP
Official title: Assessment of Cognitive and Functional Impairment of Older Patients After Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 215
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults aged 60 years or older scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC).

Brief summary: Endoscopic retrograde cholangiopancreatography (ERCP) is an interventional endoscopy procedure utilized in the therapeutic management of pancreatobiliary diseases including gallstones, bile duct strictures, leaks and infections, pancreatitis, and cancers of the bile duct or pancreas. ERCP is classified as a high risk procedure. Potential adverse events directly attributable to the technical aspects of ERCP include pancreatitis, hemorrhage, infection, and bowel wall perforation. Other potential adverse events of ERCP may be less apparent and/or unknown, such as risk of neurocognitive dysfunction. Overall, neurocognitive dysfunction after medical procedures impacts quality of life, functional disability, depression, and caregiver and societal burden.

The prevalence of postoperative neurocognitive dysfunction and disability following interventional endoscopy procedures such as ERCP has not been reported. This prospective observational study is designed to assess the prevalence of cognitive impairment and functional disability after ERCP and endoscopic ultrasound (EUS) procedures in older patients, and to assess whether specific patient and/or procedural factors are associated with increased risk of adverse outcomes.


Eligibility criteria: Inclusion Criteria:

* Adults aged 60 years or older
* Scheduled to undergo outpatient ERCP and/or EUS at Vanderbilt University Medical Center (VUMC)

Exclusion Criteria:

* Age \<60 years
* Inpatient status at the time of ERCP/EUS
* Documented history of dementia
* Inability to provide informed consent for study participation, implying baseline neurocognitive dysfunction
* Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform assessments.
* No access to a telephone to permit pre-procedure and 3 month post-procedure neurocognitive assessment

Primary outcomes:
measure: Prevalence of cognitive impairment and/or functional disability
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Patrick Yachimski, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05896254: Study of MAR001 in Adults With Metabolic Dysfunction
Official title: A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypertriglyceridemia
Lead sponsor: Marea Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* Willingness to provide informed consent and comply with the intervention
* Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
* Evidence of metabolic dysfunction at screening (triglyceride levels \> 2.8 mmol/L)

Exclusion Criteria:

* Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
* Pregnant or breastfeeding mothers
* Terminal illness with expected survival of less than 1 year

Note: additional inclusion/exclusion criteria may apply, per protocol

Primary outcomes:
measure: Safety and tolerability of MAR001
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect of MAR001 on triglyceride metabolism
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Brisbane Site
city: Melbourne
country: Australia
facility: Melbourne Site
Study officials:
affiliation: Marea Tx
name: Alex DePaoli
role: STUDY_DIRECTOR
References:
Clinical trial NCT01887054: Freezing of Gait in Parkinson's Disease
Official title: Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.

Detailed description: This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG).

This study will involve 2 study groups:

Group A - training group; Group B - no training group/controls.

Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks.

Participation in this study is expected to last 6-8 weeks.

Eligibility criteria: Inclusion Criteria:

* Age: greater than 18 years old and without an upper age limit
* diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
* Ambulate independently without an assistive device for at least 60 meters
* Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
* Willingness and ability to participate in training and complete training diary
* Documented FOG-Q and Unified Parkinson's Disease Rating Scale (UPDRS) II
* Ability to sign informed consent
* Pregnant females will be included in the study and there are no known risks to the pregnant female or fetus

Exclusion Criteria:

* Inability to complete questionnaires
* Unwillingness to participate in training, complete all questionnaires and training diary
* Subjects with secondary causes of parkinsonism
* Significant dementia (MOCA \<20)
* Prior deep brain stimulation (DBS) surgery or pallidotomy
* Subjects cannot participate in any form of Physical Therapy, Occupational Therapy or Speech Therapy during the study period
* Subjects cannot start any new medications during the study period.

Primary outcomes:
measure: Double Limb Support (DLS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Mark Stacy, MD
role: PRINCIPAL_INVESTIGATOR
References: