louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03183882: Peer Comparison Feedback on Opioid Prescribing
Official title: Effect of Peer Comparison Feedback on Opioid Prescribing by Emergency Medicine Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We aim to determine if descriptive normative feedback of peer prescribing reduces opioid analgesic prescribing by emergency medicine providers

Detailed description: State-based Prescription Drug Monitoring Programs (PDMPs) are being implemented to reduce prescription drug abuse and diversion. On August 24, 2016, Pennsylvania initiated its mandated PDMP. In prior research, we found that ED providers reduced opioid prescribing by 17% immediately after PDMP went live. Still, there is variability between providers in the frequency of opioid prescribing even after PDMP initiation. Changing clinician prescribing behavior is difficult, but recent research has shown that using peer comparisons can assist behavior change (Meeker D et al., JAMA, 2016). In this study, we will randomize a convenience sample of ED providers to receive either their opioid prescribing history data with peer comparative data or without peer comparative data. We will examine the effect on immediate perceived norms as well as impact on opioid prescribing in the subsequent 3 months. Results could inform behavioral feedback to alter clinician prescribing behaviors

Eligibility criteria: Inclusion Criteria:

* Emergency medicine provider
* Writes 10 or more opioid prescriptions per month (on average)

Exclusion Criteria:

* none

Primary outcomes:
measure: Normative beliefs
timeFrame: Pre-post intervention
measure: Number of opioid prescriptions per month
timeFrame: 3-months pre-intervention to 3-months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Emergency Department
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01626482: Effect of Kinesio Tape in Muscle Fatigue Measured by Biering-Sorensen Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Muscle fatigue affects adversely the athletes´ performance and it is therefore one of the most investigated topics currently. However we do not know accurately the mechanisms that produce it.

The aim of this study is to determine the influence of the Kinesio taping (KT) application in the paravertebral muscle fatigue in a sample of healthy young subjects.


Eligibility criteria: Inclusion Criteria:

* More than 18 years
* They were motivated to be included in the study

Exclusion Criteria:

* History of Low Back Pain (LBP) in the last 6 months that had lasted for at least 1 week and / or had required medical attention and / or had been off sick
* Back surgery
* Been diagnosed with cardiovascular disease or neurological or herniations, protrusions or severe scoliosis
* Had pain from a disease presenting infection, tumor or injury of an anatomical structure involved in the test

Primary outcomes:
measure: Time of maintenance in the Biering-Sorensen Test
timeFrame: Seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
References:
Clinical trial NCT03510182: Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
Official title: Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible participants with aphasia will receive the tDCS
Primary purpose: TREATMENT

Brief summary: Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS with intensive language therapy as a way of enhancing language outcomes in aphasia

Detailed description: Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS supplementing clinically determined intensive language therapy as a way of enhancing language outcomes in aphasia. Eligible clients enrolled in the University of Michigan Aphasia Program (UMAP) will be invited to participate in the study. Clients will receive 20 minutes of tDCS every day along with their usual treatment protocol. Pre and post testing will be completed to assess for improvement in language functioning. This is a feasibility and proof of concept study to determine if a randomized control trial should be pursued

Eligibility criteria: Inclusion Criteria:

* Diagnosis of aphasia
* Enrolled in intensive therapy program at the University of Michigan Aphasia Program.
* Ability to understand and give consent to treatment.

Exclusion Criteria:

* No metal implants or surgical devices
* History of seizures
* History of significant cognitive or psychiatric disturbance
* Participant cannot be pregnant at the time of study

Primary outcomes:
measure: Change in Controlled Oral Word Fluency
timeFrame: baseline and 4 weeks
measure: Change in Boston Naming Score
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change in Western Aphasia Quotient Score
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University Center for Language and Literacy
state: Michigan
Study officials:
affiliation: University of Michigan
name: Carol Persad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00309582: Nevirapine Levels and Fluconazole
Official title: Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy and Fluconazole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nevirapine
Fluconazole
Adverse Event
Lead sponsor: Bamrasnaradura Infectious Diseases Institute
Sponsor class: OTHER_GOV
First posted: 2006-04-03
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.


Eligibility criteria: Inclusion Criteria:

1. HIV-infected patients \>15 years of age,
2. naïve to antiretroviral therapy,
3. were initiated with a NVP-based ART regimen,
4. used NVP 200-mg once-daily lead-in dose, prior to escalation to 200 mg twice daily.

Exclusion Criteria:

1. creatinine level was higher than 2.0 mg/ml
2. liver aminotransferase enzyme was higher than five times of upper normal limit
3. receiving a medication that has drug-drug interactions with NVP or FLU

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bamrasnaradura Infectious Diseases Institute
name: Weerawat Manosuthi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02588482: Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients
Official title: Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post Anoxic Coma
Keywords: electroencephalography (EEG)
mismatch negativity (MMN)
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 50
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: The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients


Eligibility criteria: Inclusion Criteria:

* post anoxic coma
* over 18 years old
* agreement from families
* alive 4 days after the beginning of coma

Exclusion Criteria:

* traumatic coma
* non-traumatic but not anoxic coma
* patients with severe comorbidity previous to coma
* refusal of families to participate to the study
* contraindication to a high-density electroencephalography exam

Primary outcomes:
measure: Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
timeFrame: 4 days after the beginning of coma
Secondary outcomes:
measure: Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
timeFrame: 7 days after the beginning of coma
measure: Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
timeFrame: 19 days after the beginning of coma
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU Besançon
state: Franche-Comte
Study officials:
affiliation: Service de neurologie, CHRU Besançon
name: Thierry Moulin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01071382: Epidemiology of Aeromedical Evacuation
Official title: Epidemiology of Aeromedical Evacuation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apoplexy
Femoral Neck Fracture
Myocardial Infarction
Subarachnoid Hemorrhage
Polytrauma
Keywords: Aeromedical Evacuation
Repatriation
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Workers Samaritan Federation Germany
First posted: 2010-02-19
Enrollment: 504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were repatriated from abroad because of a medical emergency

Brief summary: Increasing air travel has resulted in a significant increase in aeromedical evacuation over the past decade. However there is only a small amount of epidemiological data available on the diagnosis, costs and transport characteristics of aeromedical evacuation cases. In the present study Cases of aeromedical evacuation by a relief organization (Workers' Samaritan Federation Germany) were analyzed based on the following criteria: age, sex and diagnosis of the patient, ventilation mode, days of illness before transport, type of transport, flight routes, flying time, flight distance, type of aircraft, type and distance of connecting transport from the destination airport to the final hospital, total cost per repatriation, and costs per flight-minute of each transport type.


Eligibility criteria: Inclusion Criteria:

* medical emergency and aeromedical evacuation / repatriation

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dermatologic Surgery Unit, Department of Dermatology and Allergology, Ruhr-University Bochum, Germany
name: Dr. Michael Sand
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatologic Surgery Unit, Department of Dermatology and Allergology, Ruhr-University Bochum, Germany
name: PD Dr. Falk G. Bechara
role: STUDY_DIRECTOR
affiliation: Department of Dermatology and Allergology, Ruhr-University Bochum, Germany
name: Univ.- Prof. Dr. Peter Altmeyer
role: STUDY_CHAIR
References:
citation: Sand M, Bollenbach M, Sand D, Lotz H, Thrandorf C, Cirkel C, Altmeyer P, Bechara FG. Epidemiology of aeromedical evacuation: an analysis of 504 cases. J Travel Med. 2010 Nov-Dec;17(6):405-9. doi: 10.1111/j.1708-8305.2010.00454.x.
Clinical trial NCT05154682: Pain Management After Surgery
Official title: Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following outpatient orthopaedic surgery, adequate pain control is imperative both for patient satisfaction and for improved recovery and rehabilitation. Opioids are frequently utilized for postoperative pain control, however they can be addictive and are known to have many deleterious effects. Recent studies have demonstrated the effectiveness of a wide variety of multi-modal postoperative pain regimens in providing adequate pain control while also decreasing opioid usage. However, the most effective multi-modal pain regimen for postoperative pain control remains unclear. This prospective, randomized study intends to investigate the efficacy of a multi-modal postoperative pain regimen compared to a traditional opioid-only pain regimen following elective outpatient orthopaedic surgery of the hand, wrist, foot, or ankle.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* undergoing elective outpatient orthopaedic surgery under general anesthesia.

Exclusion Criteria:

* Age \< 18 years old
* Non-English speaking
* allergy to or medical contraindication to taking oxycodone (or other opioids), acetaminophen, or Naprosyn (or other NSAIDs).
* currently taking opioid medications
* history of chronic opioid therapy for chronic pain
* surgery being performed under local anesthesia only, without general anesthesia or sedation

Primary outcomes:
measure: Postoperative Pain
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03962582: Supportive Wheelchair Back Compared to Fabric Back
Official title: Clinical Evidence for Supported Spinal Curves in Wheelchair Seating: A Randomized Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Craig Hospital
name: Motion Concepts
name: The Craig H. Neilsen Foundation
First posted: 2019-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: comparing two different back support to access if there are postural and functional differences.
Primary purpose: OTHER

Brief summary: This study tests using a wheelchair back that supports the spine in a neutral position and one that allows the spine and pelvis to fall into a posterior pelvic tilt.

Detailed description: Individuals will randomly start with the supportive back vs the unsupportive back. Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push, times forward push and ramp skills will be assessed.

Eligibility criteria: Inclusion Criteria:

* complete spinal cord injury with levels
* Full time wheelchair users
* English speaking in order to understand the consent

Exclusion Criteria:

* Over 250 pounds in body weight
* Inability to grip a wheelchair push rim
* Individual with pressure ulcer
* Individual with shoulder pain

Primary outcomes:
measure: Seated Body Measurements performed.
timeFrame: 2 hour session (one visit)
measure: Vertical Forward Reach Test (VFRT):
timeFrame: 2 hour session (one visit)
measure: Breathing status:
timeFrame: 2 hour session (one visit)
measure: One stroke push:
timeFrame: 2 hour session (one visit)
measure: Timed forward Wheeling/Wheelchair Propulsion Test (WPT):
timeFrame: 2 hour session (one visit)
measure: Ramp Ascent (forward wheeling
timeFrame: 2 hour session (one visit)
measure: Pain Scale:
timeFrame: 2 hour session (one visit)
measure: Survey
timeFrame: 2 hour session (one visit)
Secondary outcomes:
measure: Breathing status:
timeFrame: 2 hour session (one visit)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References:
Clinical trial NCT00035282: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-060)(COMPLETED)
Official title: A Double-Blind, Placebo- and Active-Controlled Acute and Extension Study of MK0869 in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 450
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: A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression.

Detailed description: The duration of treatment is 8 weeks.

Eligibility criteria: Patients with Major Depressive Disorder

Primary outcomes:
measure: HAMD-17 total score at week 8. Tolerability.
timeFrame: at week 8
Secondary outcomes:
measure: CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8
timeFrame: at week 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Liu KS, Snavely DB, Ball WA, Lines CR, Reines SA, Potter WZ. Is bigger better for depression trials? J Psychiatr Res. 2008 Jul;42(8):622-30. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.
Clinical trial NCT01400282: Analgesic Efficacy of High Frequency Spinal Cord Stimulation
Official title: Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lowback and Leg Pain
Lead sponsor: Ensemble Hospitalier de la Côte
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* treated with spinal cord stimulation
* stable pain relief achieved

Exclusion Criteria:

* failure to give informed consent
* unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.

Primary outcomes:
measure: Patient's Global Impression of Change (PGIC)
Secondary outcomes:
measure: Intensity of Pain
measure: Quality of Life (EQ-5D)
Other outcomes:
Locations:
city: Morges
country: Switzerland
facility: Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC)
city: Middlesbrough
country: United Kingdom
facility: Department of Anaesthesia, The James Cook University Hospital
Study officials:
References:
citation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Clinical trial NCT01020682: Apathy in Parkinson Disease: Clinical, Physiopathological and Pharmacological Study
Official title: Apathy in Parkinson Disease: Clinical, Physiopathological and Pharmacological Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Apathy in Parkinson Disease
Keywords: apathy
parkinson
agonist dopaminergic
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2009-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parkinson's disease

Brief summary: Apathy has been reported to occur after subthalamic nucleus stimulation (STN-DBS), a treatment of motor complications in advanced Parkinson's disease (PD). It is not known whether postoperative apathy is related to dopamine withdrawal or a side effect of STN DBS. The researchers investigated potential predictors of apathy, and the effect of dopamine agonist treatment.


Eligibility criteria: Inclusion Criteria:

* Parkinson disease

Exclusion Criteria:

* Mattis scale \< 130
* Beck scale \> 20

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital neurologique
Study officials:
References: