louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04098588: Behavioral Economics Intervention to Increase Treatment Seeking in the National Guard
Official title: Behavioral Economics Intervention to Increase Treatment Seeking in the National Guard
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment Refusal
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
Collaborators: name: Military Suicide Research Consortium
First posted: 2019-09-23
Enrollment: 112
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 study is a randomized controlled trial of a single-session behavioral economics (research combining the areas of economics, social psychology, and cognitive psychology) intervention (i.e., BEAST) is a"warrior-culture" consistent (i.e., focusing on positive soldier traits, solving practical problems), highly scalable, and extremely brief (10-minute) intervention to encourage treatment seeking among MS National Guard problems for various life stressors. Participants will be 112 National Guard members. It is hypothesized that BEAST will lead to more self-reported motivation to seek treatment and more actual treatment seeking behavior.


Eligibility criteria: Inclusion Criteria:

* National Guard active
* \> 17 ACSS-FAD

Exclusion Criteria:

* those determined by military or study personnel to be actively psychotic, manic, or who are imminently suicidal and in need of emergency services.

Primary outcomes:
measure: Psychosocial Treatments Interview-Revised
timeFrame: 1 month post intervention
measure: University of Rhode Island Change Assessment
timeFrame: 1 month post intervention
Secondary outcomes:
measure: Psychosocial Treatments Interview-Revised
timeFrame: 3 month post intervention
measure: University of Rhode Island Change Assessment
timeFrame: 3 month post intervention
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: University of Southern Mississippi
state: Mississippi
Study officials:
References:
Clinical trial NCT05481788: External Evaluation of Vancomycin Population Pharmacokinetic Models
Official title: External Evaluation of Vancomycin Population Pharmacokinetic Models and Development of Continuous Infusion Dosing Recommendations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vancomycin Dosage
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults treated with vancomycin outside of ICU

Brief summary: All patients treated with vancomycin hospitalized outside of ICU in Brest University Hospital from 1rst january 2019 to 1rst january 2021 will be screened for inclusion. Vancomycin dosage, age, weight and serum creatinin will be recorded.

Seven pharmacokinetic models' predictive performance will be evaluated on this database.

Using the best model, we will perform Monte-Carlo simulation to elaborate dosing nomograms and develop dosing recommandations of continuous infusion of vancomycin.

Detailed description: Monte Carlo simulations will be performed according to varying creatinin clearance values and weight, for both the loading dose and the maintenance dose.

Eligibility criteria: Inclusion Criteria:

* All patients hospitalized in Brest University Hospital,
* treated with vancomycin and receiving pharmacological monitoring
* between 1rst January 2019 and 1rst January 2021

Exclusion Criteria:

* Missing data on vancomycin administration
* Refusal to be included in this study
* Hospitalisation in ICU

Primary outcomes:
measure: Imprecision in Predictive performance of seven pharmacokinetic models
timeFrame: September 2021
measure: Bias in Predictive performance of seven pharmacokinetic models
timeFrame: September 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
Study officials:
References:
Clinical trial NCT04912388: Serum Cytokine Levels in Patients with Lumbal Disc Herniation and Effectiveness of Exercise
Official title: Serum Cytokine Levels in Patients with Lumbal Disc Herniation with and Without Neurological Deficits and Effectiveness of Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Disc herniation
Stabilization exercises
General exercises
Cytokines
Inflammation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study.

Detailed description: The aim of the study is to investigate serum cytokine levels and the efficacy of lumbar stabilization exercises in patients with lumbar disc herniation with and without neurological deficits. Patients who applied to Hacettepe University Hospitals Physical Medicine and Rehabilitation Department with low back pain complaints and were referred for treatment will be included in the study. Healthy individuals of similar age, height and weight will also be included for references to normal serum cytokine levels. All patients will be evaluated twice, before and 6 weeks after treatment. The treatment program will be applied 3 times a week for 6 weeks under the supervision of a physiotherapist.

Eligibility criteria: Inclusion Criteria for patients with disc herniation:

* Diagnosis of disc herniation (protrusion, extrusion, sequestered disc)
* not an indication for lumbar disc herniation surgery
* for patients with neurological deficits, loss of strength, decrease in DTRs, loss of sensation and at least one positive SLR test and presence of radicular pain
* pain intensity of VAS ≥ 3
* male and female patients between the ages of 20-55

Inclusion Criteria for heathy people

* not having low back pain complaints in the past
* female and male healthy individuals between the ages of 20-55

Exclusion Criteria:

* systemic or inflammatory disease
* pregnant or breastfeeding women
* surgery of lumbar region
* fracture of lumbar vertebrae
* lumbar scoliosis
* medication use for psychiatric disorders
* tumor
* allergy
* neurological disease
* alcohol-drug use
* generalized musculoskeletal pain

Primary outcomes:
measure: inflammatory cytokines
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Faculty of Physiotherapy and rehabilitation
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Birgül Morkoç, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184288: Proton MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.
Official title: Single Volume 1H MR Spectroscopy of Brain Metastases in Evaluation of Treatment Response.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Neoplasm Metastasis
Lung Neoplasms
Breast Neoplasms
Melanoma
Keywords: Lipid
choline
metastasis
magnetic resonance spectroscopy
treatment response
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2005-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with brain metastases

Brief summary: The aim of the study is to investigate the feasibility of in vivo single volume MR spectroscopy in evaluation of treatment response in patients with brain metastases, using 3T MR instrument. In order to optimize and avoid ineffective treatment of patients with brain metastases, in vivo MR spectroscopy can be an useful tool.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of brain metastases

Exclusion Criteria:

* children
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Faculty of Medicine
Study officials:
affiliation: Cancer clinic, St.Olavs Hospital Trondheim University Hospital
name: Steinar Lundgren, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00000188: Selegiline in Treatment of Cocaine Dependence - 2
Official title: Selegiline in Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
Selegiline
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Retention
measure: Cocaine use
measure: Cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: PDVAMC Treatment Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James Cornish, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284788: Wellness Achieved Through Changing Habits (The WATCH Study)
Official title: Wellness Achieved Through Changing Habits (The WATCH Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Overweight
Keywords: acceptance-based therapy
adolescents
weight
weight loss
obesity
overweight
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: StayWell
name: National Heart, Lung, and Blood Institute (NHLBI)
name: WellCare Health Plans, Inc.
First posted: 2017-09-15
Enrollment: 17
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.

Detailed description: Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention.

The intervention will include 15 sessions over 6 months.

A post-treatment visit will occur.

Eligibility criteria: Inclusion Criteria:

* Adolescent girls between ages 14-19 with overweight or obesity above the 85th percentile for sex and age as determined by CDC growth charts

Exclusion Criteria:

* Known pregnancy or plans to become pregnant in the next 2 years
* Any condition prohibiting physical activity
* A diagnosis of cardiovascular disease or diabetes
* Have active cancer or cancer requiring treatment in the past 2 years
* Have active or chronic infections (e.g., HIV or TB)
* Have active kidney disease or lung disease
* An eating disorder or substance abuse disorder
* Having begun a course of or changed the dosage of any medications known to affect appetite or body composition within the previous 3 months
* Weight loss greater than or equal to 5% in the previous 6 months
* If they do not follow the study plan

Primary outcomes:
measure: Number of Participants Recruited
timeFrame: Baseline; Week 8
measure: Percentage of Participants Who Did Not Complete the Intervention.
timeFrame: Baseline; Month 6
measure: Percentage of Participants Who Decide to Participate in the Intervention
timeFrame: Baseline; Week 1
measure: Percentage of Participants Who Attend All Intervention Sessions.
timeFrame: Week 1; Week 24
Secondary outcomes:
measure: Change in BMI Z-score
timeFrame: Baseline; Month 6
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: HealthStreet and University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michelle I Cardel, PhD, MS, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05271188: IPACK Block Versus Adductor Canal Block in High Tibeal Osteotomy
Official title: Infiltration of Local Anesthetic in the Interspace Between the Popliteal Artery and Capsule of the Posterior Knee "IPACK Block" Versus Adductor Canal Block "ACB" for Pain Relief After Open Wedge High Tibial Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of people who are undergoing open wedge high tibeal osteotomy aged between 40 and 60 yrs old not diabetic and neurologically free
Primary purpose: SUPPORTIVE_CARE

Brief summary: A comparison between IPACK block and adductor canal block in post operative pain management

Detailed description: Two groups of patients between 40 and 60 yrs who are undergoing open wedge high tibeal osteotomy Group 1 will receive IPACK block with 15 ml Bupivacaine, immediately before spinal anaesthesia .

Group 2 will receive adductor canal block ,also with 15 ml Bupivacaine. before spinal anaesthesia. register the time of first pain sensation and firs IV analgesic dose required in each group

Eligibility criteria: Inclusion Criteria:

1. Age 40 - 60 years.
2. American Society of Anesthiologist class ( ASA) I - III
3. BMI 18-35 kg/m2
4. Scheduled for primary unilateral open wedge high tibial osteotomy

Exclusion Criteria:

1. Known allergy to local anesthetics
2. Contraindication to local anesthetics injection e.g. infection at the site of injection
3. Contraindication to spinal anesthesia e.g. coagulopathy.
4. Patients with pre-existing motor or sensory deficits in lower extremities.
5. Insulin or noninsulin dependent diabetes mellitus.
6. systemic corticosteroid use within 30-days of surgery
7. difficulties in comprehending visual analog scale (VAS) pain scores
8. history of arrhythmia or seizures
9. severe renal insufficiency

Primary outcomes:
measure: the time of first pain sensation requiring analgesia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Salwa Hussein, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05395988: Hand Hygiene of Kindergarten Children
Official title: Hand Hygiene of Kindergarten Children: Understanding the Effect of Live Feedback on Hand Washing Behavior, Self-Efficacy and Motivation of Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Hygiene
Hand Washing
Lead sponsor: Otto-Friedrich-University Bamberg
Sponsor class: OTHER
Collaborators: name: University of Turku
First posted: 2022-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized controlled trial to further assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens will see live instructions and feedback on their hand washing activity in reals-time / while washing hands. Aim of the study is to better understand behavior change of young children.


Eligibility criteria: Inclusion Criteria:

* children attending kindergarten

Exclusion Criteria:

* none

Primary outcomes:
measure: Handwashing motivation of children (measured as soaping time by digital system).
timeFrame: up to 3 months
measure: Handwashing motivation of children (investigated with observation questionnaire for children in kindergarten)
timeFrame: up to 3 months
measure: Self-efficacy of children (investigated with interviews with children)
timeFrame: up to 3 months
measure: Self-efficacy of children (investigated with interviews with staff)
timeFrame: up to 3 months
Secondary outcomes:
measure: Sickness days of children (as recorded by kindergarten management)
timeFrame: Up to one year
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
city: Bamberg
country: Germany
facility: Otto-Friedrich-University Bamberg
Study officials:
affiliation: University of Turku
name: Sanna Salanterä, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Otto-Friedrich-University Bamberg
name: Joanna Graichen, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Anni Pakarinen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Otto-Friedrich-University Bamberg
name: Carlo Stingl, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Riitta Mieronkoski
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Glenda Dangis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537588: Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction
Official title: Changes in Muscle Morphology Resulting From ACL Reconstruction: Impact on Strength and Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Isolated Anterior Cruciate Ligament Rupture
Keywords: anterior cruciate ligament
hamstring
semitendinosus
gracilis
graft
Lead sponsor: Panam Clinic
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and apply that knowledge to the treatment and management of patients who undergo anterior cruciate ligament (ACL) reconstruction. There are three main components of this study:

1. How do muscle shape, size, strength, and ability to function change following hamstring grafting for ACL reconstruction;
2. How does physical activity change following ACL reconstruction;
3. Is there a difference in outcome if graft harvest is done from the injured versus uninjured limbs


Eligibility criteria: Inclusion Criteria:

* between 18 and 50 years old; isolated ACL rupture confirmed on MRI

Exclusion Criteria:

* other physical or mental health issues that affect ability to complete rehabilitation and/or study follow-ups

Primary outcomes:
measure: Muscle cross sectional area
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Knee flexion and extension isokinetic strength
timeFrame: 12-months post-surgery
measure: Physical activity
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Pan Am Clinic
state: Manitoba
Study officials:
affiliation: University of Manitoba, Pan Am Clinic Foundation
name: Sheila McRae, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01195688: Safety and Tolerability of BI 638683 After Single Rising Oral Doses in Healthy Male Subjects
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 63
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses


Eligibility criteria: Inclusion criteria:

healthy male subjects

Primary outcomes:
measure: Safety of BI 638683 will be assessed in a descriptive way.
timeFrame: up to 14 days post treatment
measure: Tolerability of BI 638683 will be assessed in a descriptive way.
timeFrame: up to 14 days post treatment
Secondary outcomes:
measure: To assess pharmacodynamics of BI 638683.
timeFrame: up to 5 days post study drug administration
measure: To assess pharmacokinetics of BI 638683.
timeFrame: up to 5 days post study drug administration
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1279.1.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01410188: Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Official title: An Investigator-Masked, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Keywords: open-angle glaucoma
glaucoma
ocular hypertension
intraocular pressure
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2011-08-05
Enrollment: 160
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: This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* diagnosis of bilateral primary open-angle glaucoma
* diagnosis of ocular hypertension as defined in the protocol

Exclusion Criteria:

* any form of glaucoma other than primary open-angle glaucoma in either eye
* other ocular conditions as defined by the protocol

Primary outcomes:
measure: Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.
timeFrame: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)
Secondary outcomes:
measure: Composite of Pharmacokinetics
timeFrame: 28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28)
measure: Efficacy: measurement of change in intraocular pressure from baseline.
timeFrame: 28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28)
Other outcomes:
Locations:
city: Artesia
country: United States
state: California
city: Glendale
country: United States
state: California
city: Roswell
country: United States
state: Georgia
city: Louisville
country: United States
state: Kentucky
city: Washington
country: United States
state: Missouri
city: High Point
country: United States
state: North Carolina
city: Maryville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Kubota Vision Inc.
name: John W Chandler, MD
role: STUDY_DIRECTOR
References: