louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04854954: Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury
Official title: Prediction of Secondary Neurological Deterioration in Patients With Moderate Traumatic Brain Injury : an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 142
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: All adults admitted in Brest hospital (ICU and wards) between 2015 and 2018 for moderate TB

Brief summary: Patients with moderate traumatic brain injury (mTBI) are 1,5 times more frequent than those with severe TBI and some of them will develop secondary neurologic deterioration (SND) within the first 7 days. However, identifying at risk patients of SND is still challenging. This study aimed to determine risk factors associated with SND after mTBI.


Eligibility criteria: Inclusion Criteria:

* Adults
* Admitted in Brest hospital between 2015 and 2018 for moderate TBI, defined by Glasgow coma scale (GCS) score 9-13

Exclusion Criteria:

* Non consenting patients

Primary outcomes:
measure: Secondary neurologic deterioration
timeFrame: Within 7 days after hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04143854: Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines
Official title: Phase II, Randomized, Double-blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Lateral Canthal Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 150
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: This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 65
* Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile as assessed by both investigator and subject using FWS

Exclusion Criteria:

* History of facial nerve paralysis
* Any eyebrow or eyelied ptosis as determined by the investigator

Primary outcomes:
measure: Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maroubra
country: Australia
facility: Maroubra Medical Centre
state: New South Wales
Study officials:
References:
Clinical trial NCT02122354: Triggers and Responses to Simulator Sickness in Videogame Players
Official title: Data Collection and Analysis on Simulator Sickness Case Parameters in Susceptible Videogame Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulator Sickness
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this research is the accumulation of gameplay data and simulator sickness background surveys for trend analysis, and individual simulator sickness trigger factor analysis for the test subjects involved. Rather than isolating specific variables for hypothesis formulation, this study will be attempting to collect an array of data that is a) both qualitative and quantitative, and b) observational and test subject-reported. The final results will consist of a list of possible trigger factors to avoid for individual subjects, and metrics showing the directional tendencies of players depending on the severity of their symptoms at the time.

The overall goal of this research is to better understand factors that contribute to simulator sickness, both in who it affects and why some gameplay experiences may cause it more than others. Operating from the basic assumption that the way a player moves through an environment affects how quickly that player gets sick, we will primarily be gathering data on how the player moves through the digital space and whether that behavior changes once they begin to feel sick.


Eligibility criteria: Inclusion Criteria:

* Survey participants should have some experience with playing videogames or similar interactive simulations on 2D displays.
* At least one-half of research participants should have experienced simulator sickness at some point in recent memory (within the past year) in response to a simulated experience.

Exclusion Criteria:

* Players under 18 will be excluded from participating in the experimental portion of the project.
* manual dexterity deficit or inability to use the gameplay interface
* Non-English speakers
* Acute state of illness.

Primary outcomes:
measure: Survey of triggers to simulator sickness in videogame players (global)
timeFrame: Baseline
Secondary outcomes:
measure: Survey of responses to simulator sickness in videogame players (global)
timeFrame: Baseline
measure: Real-time player responses to simulator sickness
timeFrame: During intervention
Other outcomes:
measure: Post-play simulator sickness rating
timeFrame: Post-exposure to intervention
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Michael Lin, MFA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Marientina Gotsis, MFA
role: STUDY_CHAIR
References:
Clinical trial NCT04940754: Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture
Official title: Ankle Arthrodesis Nail Combined With Locking Compression Plate to Stabilize Two-level Pathologic Tibial Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Metastases
Fracture Nonunion
Bone Lesion
Keywords: fragility fracture, old age
Lead sponsor: Orthopaedie Zentrum Zuerich
Sponsor class: NETWORK
First posted: 2021-06-28
Enrollment: 1
Sex: FEMALE
Minimum age (years): 80
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Use of an approved implant for expanded application
Primary purpose: TREATMENT

Brief summary: Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures

Detailed description: The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,

Eligibility criteria: Inclusion Criteria:

- old age, fragility fracture, tibia

Exclusion Criteria:

* active osteomyelitis

Primary outcomes:
measure: Weight bearing tolerance
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Orthopaedie Zentrum Zuerich
Study officials:
References:
Clinical trial NCT02583854: Comparison Study of Compression Devices Used in Transradial Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Occlusion
Hemostasis
Injury of Radial Artery
Keywords: Coronary angiography
Transradial
Patient experience
VAS
Compression device
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Sor-Ost
First posted: 2015-10-22
Enrollment: 499
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis.

Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications.

The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary angiograms via the transradial route

Exclusion Criteria:

* Patients who have a long way to travel for the follow up, ultrasound scan
* Patients that do not understand Norwegian
* Patients presenting with acute ST segment elevation myocardial infarction (STEMI)

Primary outcomes:
measure: Radial artery occlusion
timeFrame: 90-120 days
Secondary outcomes:
measure: Patient experience
timeFrame: 1-4 hours
measure: Device complications
timeFrame: 1-4 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Due-Tonnessen N, Egeland CH, Meyerdierks OJ, Opdahl A. Is radial artery occlusion and local vascular complications following transradial coronary procedures affected by the type of haemostasis device used? A non-inferiority Randomized Controlled Trial (RadCom trial). Eur J Cardiovasc Nurs. 2021 Aug 20;20(6):580-587. doi: 10.1093/eurjcn/zvab004.
Clinical trial NCT00255554: DBT and Escitalopram in Borderline Personality Disorder
Official title: Effects of Dialectical Behavioral Therapy and Escitalopram on Impulsive Aggression, Affective Instability and Cognitive Processing in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
BPD
Dialectical Behavior Therapy
DBT
Escitalopram
Lexapro
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2005-11-21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects will receive six months of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist. Half the subjects will concurrently receive escitalopram while half will receive placebo, in a randomized double-blind design.


Eligibility criteria: Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has been off psychotropic medications for at least 2 weeks (6 weeks for fluoxetine).

-

Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation, current or recent Substance Dependence or a current Major Depressive Episode. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.)

-

Primary outcomes:
measure: Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
Study officials:
affiliation: Bronx VA Medical Center/Mount Sinai School of Medicine
name: Marianne Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
Clinical trial NCT00762554: Depodur vs Fentanyl Infusion for Post-C/S Analgesia
Official title: A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Analgesia
Keywords: analgesia
cesarean section
fentanyl
Depodur
Post-cesarean section analgesia
Lead sponsor: Goodman, Evan, M.D.
Sponsor class: INDIV
First posted: 2008-09-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section
* Patient appropriate for regional anesthesia
* Patient agrees to receive regional anesthesia
* Patient willing to have an epidural infusion of medication for two days postoperatively

Exclusion Criteria:

* Morbid obesity
* History of sleep apnea
* Allergy to opioids medications
* History of opioids use during week prior to procedure
* Emergency cesarean section
* Significant surgical complications
* Contraindication or refusal to have regional anesthesia
* Age less than 18

Primary outcomes:
measure: Degree of analgesia (measured on a 10-point scale)
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: Frequency of minor side effects, such as pruritis or nausea.
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
References:
citation: Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoDur Study Group. Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study. Anesth Analg. 2005 Apr;100(4):1150-1158. doi: 10.1213/01.ANE.0000149544.58230.FF.
citation: Carvalho B, Roland LM, Chu LF, Campitelli VA 3rd, Riley ET. Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. Anesth Analg. 2007 Jul;105(1):176-83. doi: 10.1213/01.ane.0000265533.13477.26.
Clinical trial NCT06331754: Technology-Enabled Remote Hypertension Management To Advance Health Equity
Official title: Technology-Enabled Remote Hypertension Management To Advance Health Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Atman Health, Inc
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-blinded pragmatic cluster-randomized controlled trial with a single intervention
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization.

Detailed description: The study design is a non-blinded pragmatic cluster-randomized controlled trial with a single intervention. Participants with uncontrolled hypertension will be identified from a randomly selected group of primary care clinics. Participants from half of the clinics will be enrolled in the intervention arm while the others will receive usual care. Participants in the intervention arm will undergo a series of software-driven medication initiation and titration steps until they reach a blood pressure target of systolic blood pressure \< 130 mmHg and diastolic blood pressure \< 80 mmHg. Participants will be subsequently monitored for up to 12 more months.

Eligibility criteria: Inclusion Criteria:

* 18 years - 100 years
* uncontrolled hypertension: as defined as SBP \> 140 or DBP \> 90 on 2 successive clinic visits

Exclusion Criteria:

* hearing impaired
* visually impaired
* cognitively impaired
* hospice care
* on hemodialysis at enrollment
* New York Heart Association Class IV heart failure

Primary outcomes:
measure: Difference in SBP change
timeFrame: 6 months after enrollment
Secondary outcomes:
measure: HEDIS proportion
timeFrame: 6 months after enrollment
measure: Difference in DBP change
timeFrame: 6 months after enrollment
Other outcomes:
measure: Home measured change in SBP and DBP
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Provider satisfaction
timeFrame: 6 months
measure: Mean time required per patient for provider
timeFrame: 6 months
measure: Mean time required per patient for navigator
timeFrame: 6 months
measure: Proportion of patients measuring blood pressure at directed frequency
timeFrame: 6 months
measure: Resource utilization
timeFrame: 18 months
Locations:
Study officials:
References:
Clinical trial NCT01692054: Risk and Protective Factors of Children and Adolescents Who Were Hospitalized Due to Alcohol Intoxication
Official title: Prediction and Detection of Intermediate and Long-term Developmental Hazards in Adolescents After Alcohol Intoxication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Use Disorders
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 394
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: young adults living in Germany who were hospitalized due to alcohol intoxication (experimental group) or other medical conditions (control group) 5 to 12 years ago

Brief summary: The aim of the study is to improve the prognosis of the development of alcohol consumption by considering a variety of biological, psychological and social risk and protective factors. Therefore, young people who have been hospitalized due to acute alcohol intoxication within the past 5 to 12 years will be interviewed in order to assess aspects of healthy or impaired psychosocial development. The study will also include a control group of young adults who were in hospital due to other medical conditions. The identification of relevant cases will be based on medical records of several children's hospitals. These records will be analysed with regard to potential predictors of developmental hazards and protective factors.


Eligibility criteria: experimental group:

Inclusion Criteria:

* male and female volunteers who were hospitalized due to acute alcohol intoxication from January 1, 2000 to December 31, 2006
* written informed consent by the subject
* minimum age of 20 years

Exclusion Criteria:

* incapability to conduct interview

control group:

Inclusion Criteria:

* male and female volunteers who were hospitalized due to other medical conditions but not acute alcohol intoxication from January 1, 2000 to December 31, 2006
* written informed consent by the subject
* minimum age of 20 years

Exclusion Criteria:

* incapability to conduct interview

Primary outcomes:
measure: Alcohol Use Disorders
timeFrame: 5 to 13 years
Secondary outcomes:
measure: Self-efficacy
timeFrame: 5 to 13 years
measure: Life Satisfaction
timeFrame: 5 to 13 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
state: Saxony
Study officials:
affiliation: Universitaetsklinikum Carl Gustav Carus at the Technische Universitaet Dresden
name: Ulrich Zimmermann, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111954: Ga-68-NODAGA-MJ9 Compared to F-18-FCH PET/CT for Prostate Cancer Patients
Official title: PET/CT Study of GRP Receptors With Ga-68-NODAGA-MJ9 in Prostate Cancer Compared to F-18-FCH PET / CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
primary
recurrence
F-18-FCH PET/CT
Ga-68-NODAGA-MJ9 PET/CT
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 60
Sex: MALE
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: Patient with proven prostate cancer

Brief summary: Prostate cancer patients for whom a F-18-FCH PET/CT is indicated. Ga-68-NODAGA-MJ9 is a new PET/CT radiotracer aiming at giving complementary information : more precise images and early localisation of recurrence to standard imaging

Detailed description: Patient with primary or relapsing prostate cancer for whom F-18-FCH PET/CT is indicated will be proposed to participate to the present study. After signing the patient informed consent, both F-18-FCH and Ga-68-NODAGA-MJ9 PET/CT will be scheduled with a maximum 10 day-interval.

No adverse events are expected.

Eligibility criteria: Inclusion Criteria:

* Age : adult patients
* Karnofsky : ≥ 80%
* Patients with histologically proven prostate cancer for whom 18F-fluocholine PET/CT is indicated for primary cancer staging, or for recurrence with increase of blood PSA. In order to provide a detection probability of 30% or more, a blood PSA 0.5 ng / ml or more in post initial curative intent surgery will be required.
* Signed informed consent.

Exclusion Criteria:

* Lack of discernment to sign the consent form
* Age \<18 years
* Patient under hormonal treatment

Primary outcomes:
measure: Positivity of the new radiotracer Ga-68-NODAGA-MJ9 compared to the standard radiotracer F-18-FCH
timeFrame: At baseline (after F-18-FCH PET/CT)
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: John O. Prior, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnesin S, Cicone F, Mitsakis P, Van der Gucht A, Baechler S, Miralbell R, Garibotto V, Zilli T, Prior JO. First in-human radiation dosimetry of the gastrin-releasing peptide (GRP) receptor antagonist 68Ga-NODAGA-MJ9. EJNMMI Res. 2018 Dec 12;8(1):108. doi: 10.1186/s13550-018-0462-9.