louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00934947: Burn Healing and Analgesia With Propranolol
Official title: The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burns
Pain
Keywords: Burns
Pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.


Eligibility criteria: Inclusion Criteria:

* Thermal burn
* Greater than or equal to 18 years of age
* Less than 60 years of age
* Able to speak and read English

Exclusion Criteria:

* Intubated
* Clinically unstable
* Other substantial comorbid injury (e.g. long bone fracture)
* Heart block greater than first degree (EKG)
* History of coronary artery disease
* History of congestive heart failure
* Asthma (within past 10 years, induced by a beta-blocker, or receiving current treatment)
* Pregnant
* Prisoner
* Psychotic, suicidal, or homicidal
* Diabetic
* Hepatic failure (acute or chronic)
* Renal failure (acute or chronic)
* History of hyperthyroidism unless taking synthroid or other thyroid hormone replacement
* Exceeds daily acceptable chronic opioid use prior to burn
* Interacting medication
* Received propranolol within the last 6 months
* Multiple severe allergic reactions
* On daily methylphenidate or similar stimulant medication
* Unwilling to use medically acceptable birth control (if childbearing potential)
* Breastfeeding
* Severe peripheral vascular disease or vasospastic disorder
* Bradycardia that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history
* Other criteria that in investigator's opinion makes participant poor candidate for the trial
* Cancer (except basal cell cancer)

Primary outcomes:
measure: Overall Pain Trajectory Slopes
timeFrame: Study days 5, 7, 10, 13, 17 and 19
Secondary outcomes:
measure: Sleep Quality
timeFrame: 6 weeks after injury timepoint was chosen for this analysis
measure: Itch Symptoms
timeFrame: Week 6 after injury was chosen as the main timepoint of interest
measure: Anxiety Symptoms
timeFrame: 6 weeks after injury was chosen as the main timepoint of interest
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Chapel Hill
country: United States
facility: North Carolina Jaycee Burn Center
state: North Carolina
city: Wake Forest
country: United States
facility: Wake Forest University Baptist
state: North Carolina
city: Upland
country: United States
facility: Crozer Chester Medical Center
state: Pennsylvania
Study officials:
affiliation: University of North Carolina, Department of Anesthesiology
name: Samuel McLean, MD, MPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00348647: Prevention of Injuries by an Exercise Program - a RCT
Official title: Can Lower Extremity Overuse Injuries Be Prevented by an Exercise Program Aiming at Muscular Strength, Flexibility and Coordination - a RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Exertional Lower Leg Pain
Keywords: Prevention
Exercise
Overuse
Anterior knee pain syndrome
Exertional lower leg pain
Prospective
Risk factors
Hip
Lead sponsor: Amager Hospital
Sponsor class: OTHER
First posted: 2006-07-04
Enrollment: 900
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: Overuse injuries are a major concern for physical active individuals. Study hypothesis is that an exercise programme based on known intrinsic risk factors can prevent overuse injuries in soldiers undergoing basic military training.

Detailed description: PURPOSE: Overuse injuries are a major concern for physical active individuals engaged in endurance type activities. This is especially true for soldiers during basic military training or subjects with a sedentary lifestyle taking up exercise to prevent disease, as they are vulnerable for sustaining an overuse injury. Contradictory to traumatic injuries, little is known about the prevention of overuse injuries using a training program. This study evaluates the preventive effect of a training program based on known intrinsic risk factors for the occurrence of anterior knee pain and shin pain in soldiers undergoing basic military training. We also evaluate the effect on physical performance.

METHODS: From December 2004 - March 2006 1000 soldiers undergoing basic military training divided into 24 platoons are cluster randomised into a prevention-training (PRE) group or a placebo-training (PLA) group. The PRE group will perform exercises based on known intrinsic risk factors namely strength, flexibility and coordination of the lower extremity, while the PLA group will perform exercises for the upper body. Both programmes consists of 5 exercises and will be performed 3 times a week during a 12 weeks period. All subjects will prospectively be examined by the same observer, who will be blinded to the allocation.

OUTCOME: primary outcome: reduction in anterior knee pain and shin pain.

Eligibility criteria: Inclusion Criteria:

* Basic military training in the Royal Danish Guards.
* Passed military medical board.

Exclusion Criteria:

* Injury before start of intervention

Primary outcomes:
measure: reduction in anterior knee pain
measure: reduction in shin pain
Secondary outcomes:
measure: reduktion in overuse injuries
measure: physical performance
Other outcomes:
Locations:
Study officials:
affiliation: Amager Hospital DK-2300 Amager
name: Christoffer Brushoj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00830947: Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
Official title: The OrthoAccel (OATI) Celerect Device Pivotal Study - Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malocclusion
Keywords: Orthodontic
Extraction
Device
Space Closure
Orthodontic malocclusion
Lead sponsor: OrthoAccel Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To gather data indicating whether or not the OrthoAccel device speeds tooth movement in people who use orthodontics (braces).

Detailed description: This is a randomized, blinded study that will follow 32 patients for up to six months. Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving the anterior teeth or canine distally. Patients will have standard orthodontic treatment and temporary anchorage devices for tooth movement and space closure. Half the patients will receive a functioning device and half the patients will receive a sham-device. Patients will use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a light vibration.

Eligibility criteria: Inclusion Criteria:

* Permanent dentition between the ages of 12 and 40
* Minimum of 3 mm of extraction space to be closed by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines
* Good oral hygiene and compliance

Exclusion Criteria:

* Any compromised medical or dental condition
* Patient currently involved in any other study
* Lives significantly outside San Antonio, TX
* use of bisphosphonates
* pregnant females

Primary outcomes:
measure: The Rate of Orthodontic Movement of a Maxillary Canine Tooth Being Distalized to Close an Extraction Space.
timeFrame: Time to Space Closure, an average of 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Ravi Anthony
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Peter Gakunga, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04114747: Renal Physiology During Continuous Renal Replacement Therapy
Official title: Impact of Continuous Renal Replacement Therapy on Renal Oxygenation, Blood Flow and Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AKI
Continuous Renal Replacement Therapy
Dialysis
Intensive Care
Renal Blood Flow
Renal Failure
Blood Pressure
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To describe renal physiology parameters when starting CRRT and compare renal physiology parameters when using high blood pressure target (MAP 80-90 mmHg) and low blood pressure target (MAP 60-70 mmHg).
Primary purpose: PREVENTION

Brief summary: Approximately 50% of patients in the intensive care unit (ICU) develop acute kidney injury (AKI) and more than 10% need dialysis. There is no treatment for AKI. Care is aiming for optimization of circulation and blood flow to the kidneys and avoiding nephrotoxic agents.

There is conflicting data concerning whether early or late dialysis is harmful for the kidneys. No one has examined the physiological changes in the kidney when starting dialysis and which blood pressure that leads to most optimal physiological conditions for the kidneys during dialysis. In this descriptive study of 20 ICU patients suffering from AKI we aim to investigate renal physiology when starting continuous renal replacement therapy (CRRT) and also at different target blood pressures using retrograde renal vein thermodilution technique. In parallel we will also investigate and validate this invasive method with contrast enhanced ultrasound of the kidneys.


Eligibility criteria: Inclusion Criteria:

AKI, according to KDIGO, stage 2 or 3 but with preserved urine production. Treated in the ICU at Sahlgrenska University Hospital Written, signed informed consent Male and female subjects ≥18 years

Exclusion Criteria:

Emergency need for dialysis Allergy to contrast media (used for CEUS)

Primary outcomes:
measure: Renal blood flow and CRRT
timeFrame: 6 hours
measure: Renal blood flow and blood pressure
timeFrame: 6 hours
measure: Glomerular filtration rate (GFR) and blood pressure
timeFrame: 6 hours
measure: Glomerular filtration rate (GFR) and CRRT
timeFrame: 6 hours
measure: Renal oxygenation during CRRT
timeFrame: 6 hours
measure: Renal oxygenation and blood pressure
timeFrame: 6 hours
Secondary outcomes:
measure: Contrast enhanced renal ultrasound (CEUS)
timeFrame: 2 hours
measure: atrial natriuretic peptide (ANP)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
name: Kristina Svennerholm, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223347: Improved and Simplified Staining Technique for Dysplasia Detection in Colitis
Official title: A Prospective Trial Comparing Chromoendoscopy to a Digital Staining Technique and White Light in High Definition Colonoscopy in Patients With IBD Attending Scheduled Surveillance Colonoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colitis
Colonic Dysplasia
Inflammatory Bowel Diseases
Colonoscopy
Surveillance
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-01-25
Enrollment: 106
Sex: ALL
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: Our study is directed to the IBD patients who have to undergo a surveillance colonscopy to early detection of dysplasia.

Brief summary: Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy

Detailed description: In this study we will attempt to compare dye based chromoendoscopy to WLI (white light), NBI( Narrow Band Imaging) and TXI( Texture and Colour Enhancement Imaging). High Definition Colonoscopy is used. We aim to compare all these dye/lights to each other and find the best and simplest method to help to diagnose dysplasia more efficient and easier.

Eligibility criteria: Inclusion Criteria:

- Person schedules to IBD- surveillance colonoscopy.

Exclusion Criteria:

* Total Colectomy.
* Not well prepared Bowel. BBPS under 2 at any segement.
* Pregnancy.

Primary outcomes:
measure: Dysplasia detection rate
timeFrame: 90 minutes
Secondary outcomes:
measure: Hyperplasia detection rate
timeFrame: 90 minutes
measure: Adenoma detection rate, ADR
timeFrame: 90 minutes
measure: Bowel cleansing quality according to Bowel Boston Preparation Scale
timeFrame: 90 minutes
measure: Serious adverse events (significant bleedings and perforations)
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Molndal
Study officials:
References:
Clinical trial NCT06215547: Medtronic Enterra II Neurostimulator
Official title: Medtronic Enterra II Neurostimulator
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Gastroparesis
Keywords: nausea
vomiting
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 500
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: Medtronic - Enterra II Neurostimulator
Primary purpose: TREATMENT

Brief summary: Humanitarian Device: Authorized by Federal (U.S.A.) Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Detailed description: Description The Medtronic Enterra II Model 37800 Neurostimulator is a programmable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system.

These components comprise the implantable portion of the Medtronic Enterra II system.

The operation of the neurostimulator is supported by a clinician programmer. The neurostimulator (Figure 1) operates on a sealed battery and electronic circuitry to provide controlled electrical pulse stimulation, through the implanted lead system.

A wide range of noninvasively programmable parameters and stimulation modes are available. The neurostimulator provides current parameter information, via telemetry, when used with the clinician programmer.

System Components

* Neurostimulator: Medtronic Enterra II Model 37800
* Controlling Devices: Medtronic Model 8840 Clinician Programmer with Model 8870 Application Card. Model 8527 Printer optional.
* Lead: Medtronic Enterra Model 4351 Unipolar Lead

Eligibility criteria: Inclusion Criteria:

* chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years.

Exclusion Criteria:

* Organ transplant
* Organic obstruction
* Pseudo-obstruction
* Prior gastric surgery
* Scleroderma
* Amyloidosis
* History of seizures
* Peritoneal or unstable dialysis
* Chemical dependency
* Pregnancy
* Primary eating or swallowing disorders
* Psychogenic vomiting
* Implanted electronic medical devices
* Age \< 18 or \> 70 years

Primary outcomes:
measure: Treating Self Reported Nausea and Vomiting using Enterra II during procedure
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: Methodist Richardson Medical Center
state: Texas
Study officials:
affiliation: Methodist Heath System
name: Sachin Kukreja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597947: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) ACHN-975 in Normal Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Defense Medical Research and Development Program
First posted: 2012-05-15
Enrollment: 50
Sex: ALL
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: This is a double-blind, randomized, placebo-controlled, single ascending dose study to assess the safety, tolerability, and PK of ACHN-975 in normal healthy volunteers. This study will take place in the US at one clinical site.


Eligibility criteria: Key Inclusion Criteria:

* Body weight between 40 and 100 kilograms (between \~88 pounds and \~220 pounds)
* Use of contraception
* Stable health
* Negative tests for alcohol, tobacco, and drugs of abuse

Key Exclusion Criteria:

* History of clinically significant disease
* Pregnancy

Primary outcomes:
measure: Frequency of AEs
timeFrame: 7 days
measure: Severity of AEs
timeFrame: 7 days
Secondary outcomes:
measure: Plasma concentrations of ACHN-975
timeFrame: 2 days
measure: Urine concentrations of ACHN-975
timeFrame: 2 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Investigational Site
state: North Carolina
Study officials:
affiliation: Achaogen, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01170247: Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation in Pediatric Patients
Official title: Intranasal Ketamine Versus Intramuscular Ketamine for Procedural Sedation: A Prospective Randomized, Double-blinded, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sedation
Keywords: Procedural Sedation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 3
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if intranasal ketamine is equally as effective and safe as intramuscular ketamine for procedural sedation in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* pediatric patients age 2 to 17 years old
* have a laceration of 4 cm on the face or 7 cm on the remainder of the body
* Require procedural sedation to repair the laceration

Exclusion Criteria:

* Patients with abnormal nasal physiology which would not allow for adequate medication delivery
* Unable to have a guardian present to consent on their behalf
* Allergy to ketamine
* Significant cardiac history (myocardial ischemia, heart failure, arrhythmias)
* Presenting with a head injury associated with possible intracranial hypertension
* Pregnancy
* Lacerations that require repair from a consult service

Primary outcomes:
measure: Onset of Sedation
timeFrame: Every 60 seconds through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Christopher Hogrefe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Brett Faine, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Andrew Nugent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316947: Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes
Official title: Developing and Pilot Testing an Intervention to Reduce Household Shisha Smoke Exposure Within Somali Homes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shisha
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a feasibility pilot of the new CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families.
Primary purpose: OTHER

Brief summary: Previous qualitative research among Somali American adults in Minnesota have identified high levels of hookah or shisha (hereafter shisha) use in Somali households. Household shisha use exposes all family members, including children, to secondhand smoke (SHS) that contains toxins that can cause many different acute and chronic disease, including increased levels of several cancers such as lung, bladder, and oral cancers. Despite the high levels of shisha use, gaps in the knowledge of the risks of shisha use and how to mitigate the potential harmful health consequences of shisha use exist among Somali Americans.

This study aims to pilot test the feasibility of a newly developed CHW-delivered intervention to reduce home shisha SHS exposure with n=15 Somali families. Pre-/post-measurements of family members' (1 adult and 1 child) urine or salivary cotinine levels will be obtained along with a brief pre-/post-survey to characterize household tobacco use and the presence of home smoke-free rules.


Eligibility criteria: Inclusion Criteria:

Eligible families will identify as

* Somali American,
* have one or more children between 6 months and 18 years of age in the home, and
* have at least one adult who uses shisha at home. Families with other forms of tobacco use in addition to shisha use will be included.

Exclusion Criteria:

* Participation in previous qualitative study to inform intervention development
* Inability or unwillingness to provide informed consent and complete all study procedures

Primary outcomes:
measure: Recruitment rate
timeFrame: 8 weeks
measure: Retention rate measure
timeFrame: 8 weeks
measure: pre-/post- survey completion rates
timeFrame: 8 weeks
measure: pre-/post- biospecimen completion rates
timeFrame: 8 weeks
Secondary outcomes:
measure: shisha use changes
timeFrame: 8 weeks
measure: tobacco product use changes
timeFrame: 8 weeks
measure: smoke-free home rules
timeFrame: 8 weeks
measure: the cotinine levels of parents and children.
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: April Wilhelm, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: