louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02826642: A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
Official title: A Phase I, Open Label, Multicenter, Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acute Myeloid Leukemia (AML)
Keywords: newly diagnosed acute myeloid leukemia
AML
myeloid dysplastic syndrome
MDS
IDH305
standard of care in IDH1 mutant acute myeloid leukemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).


Eligibility criteria: Inclusion Criteria:

-- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.

* Documentation of IDH1R132 mutation of tumor
* ECOG performance status ≤ 2
* Clinically fit for standard of care medication per protocol.

Exclusion Criteria:

* Prior treatment for AML or MDS
* Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
* Acute Promyelocytic Leukemia
* Women who are pregnant or lactating

Other protocol-defined Inclusion/Exclusion may apply

Primary outcomes:
measure: Dose Limiting toxicities
timeFrame: 10 months
measure: Number of patients with adverse events (AEs)
timeFrame: 36 months
Secondary outcomes:
measure: Area Under Curve (AUC)
timeFrame: 36 months
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 36 months
measure: Time taken to reach maximum plasma concentration (Tmax)
timeFrame: 36 months
measure: Complete remission rate (CRR)
timeFrame: 36 months
measure: Overall response rate (ORR)
timeFrame: 36 months
measure: Event free survival (EFS)
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06980142: A Study of CM512 in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating CM512 Injection in Subjects With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 204
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Study to Explore the Efficacy and Safety of CM512 Injection in Adults with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Detailed description: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of CM512 in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) receiving triple or double inhaled maintenance therapy, and having had 1 or more documented COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive CM512, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Eligibility criteria: Inclusion Criteria:

* 40 to ≤ 80 years old

  * BMI ≥ 18.0 kg/(m\*m)
  * COPD diagnosis≥1 year
  * Post-BD FEV1 ≥ 30% and \< 80%, FEV1/FVC \<0.70 at screening
  * Triple (LABA+LAMA+ICS) or dual inhaled (LABA+LAMA or LABA+ICS) COPD therapy ≥3 months prior to V1
* 2 moderate or ≥1 severe COPD exacerbations in the prior year

  * CAT ≥10 at screening
  * Former or current smokers ≥10 pack-years

Exclusion Criteria:

* Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
* Treatment with oxygen of more than 15 hours per day.
* Pregnant or breastfeeding.
* The chest/lungs with pathology that precludes the patient's ability to complete the study.

Primary outcomes:
measure: Annualised rate of moderate or severe COPD exacerbations
timeFrame: Baseline up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Huadong Hospital
name: Jinfu Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03765242: Evaluation of Safety and Effectiveness on Oral Anticoagulants
Official title: Retrospective Medical Chart Review Study for Atrial Fibrillation Patents Treated With Oral Anticoagulant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2018-12-05
Enrollment: 12354
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria

Brief summary: This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment


Eligibility criteria: Inclusion Criteria:

* Individuals greater than or equal to 20 years old as of the index date
* At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
* Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date

Exclusion Criteria:

* Patient's medical records indicating pregnancy during the follow-up period
* Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
* Had \> 1 OAC prescription in the patient's medical records on the index date

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of major bleeding among oral anticoagulant (OAC) initiators
timeFrame: Maximum 3 years
Secondary outcomes:
measure: Incidence of thromboembolic events
timeFrame: Maximum 3 years
measure: Incidence of stoke/SE (secondary event) among OAC initiators
timeFrame: Maximum 3 years
measure: Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr
timeFrame: Maximum 3 years
measure: Incidence of cardiovascular/all cause death among OAC initiators
timeFrame: Maximum 3 years
measure: Incidence of myocardial infarction among OAC initiators
timeFrame: Maximum 3 years
measure: Incidence of major adverse cardiac event among OAC initiators
timeFrame: Maximum 3 years
measure: Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate)
timeFrame: Maximum 3 years
measure: Incidence of myocardial infarction among OAC initiators stratified by CCr
timeFrame: Maximum 3 years
measure: Incidence of major adverse cardiac event among OAC initiators stratified by CCr
timeFrame: Maximum 3 years
measure: Distribution of clinical characteristics among OAC initiators
timeFrame: Maximum 3 years
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04014842: RapidShock Post-Approval Study
Official title: Post-Approval Study for Reconfirmation Analysis Mode Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 2756
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare the performance of the Reconfirmation Analysis Mode algorithm to the performance goals recommended by the American Heart Association.


Eligibility criteria: Inclusion Criteria:

* 8 years of age or older and weight ≥ 55 lbs (25 kgs)
* Out-of-hospital cardiac arrest (OOHCA)
* Non-traumatic cardiac arrest

Exclusion Criteria:

* Weight less than 55 lbs (25 kgs)
* Do not attempt resuscitation (DNAR) orders

Primary outcomes:
measure: Algorithm accuracy
timeFrame: average of up to 1 hour after device placement
Secondary outcomes:
Other outcomes:
Locations:
city: Camarillo
country: United States
facility: Ventura County Fire Department
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Fire Department
state: Colorado
city: Baton Rouge
country: United States
facility: East Baton Rouge Parish EMS
state: Louisiana
city: Detroit
country: United States
facility: Detroit Fire Department
state: Michigan
city: Saint Paul
country: United States
facility: M Health Fairview EMS
state: Minnesota
city: Fort Worth
country: United States
facility: Fort Worth Fire Department
state: Texas
city: San Antonio
country: United States
facility: San Antonio Fire
state: Texas
Study officials:
References:
Clinical trial NCT02248142: Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)
Official title: Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 1029
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from moderate to severe RLS recruited at office-based neurologists

Brief summary: Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)


Eligibility criteria: Inclusion Criteria:

* Patients suffering from primary RLS who are planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study
* Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication
* Male or female patients of any age

Exclusion Criteria:

* Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) for the treatment with pramipexole

Primary outcomes:
measure: Assessment of RLS symptoms (IRLS) on a 4-point rating scale
timeFrame: up to 12 weeks
measure: Assessment of RLS severity on a 6-point rating scale
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale
timeFrame: up to 12 weeks
measure: Global assessment of efficacy by investigator on a 5-point scale
timeFrame: after 12 weeks
measure: Number of patients with adverse events
timeFrame: up to 12 weeks
measure: Time to reach maintenance dose of pramipexole
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06657742: Validity and Reliability of SCIM-SR
Official title: Validity and Reliability of the Turkish Version of the Spinal Cord Independence Measure Self-Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -SCI patients between the ages of 18-70 and at least 1 month after their injury

Brief summary: To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR.

Detailed description: To determine the validity and reliability of SCIM-SR, patients will fill out SCIM 3 and SR. scım-sr Turkish form has been created. Patients with spinal cord injuries who applied to our physical therapy clinic filled out the form twice.

Eligibility criteria: Inclusion Criteria:

* SCI \>1 month
* 18-70 years
* agree to participate
* give written consent

Exclusion Criteria:

* not read Turkish,
* not write Turkish,
* cognitive problems

Primary outcomes:
measure: SCIM-SR
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cansın Medin Ceylan
state: None Selected
Study officials:
References:
Clinical trial NCT02103842: Omega-3 Fatty Acids to Combat Sarcopenia
Official title: Omega-3 Fatty Acids to Combat Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sarcopenia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how omega-3 fatty acids influence muscle protein metabolism and mitochondrial physiology in the context of human aging.


Eligibility criteria: Inclusion Criteria:

* Age 18-35 or 65-85 years

Exclusion Criteria:

1. Current use of omega-3 nutritional supplements
2. Fasting plasma glucose ≥126 mg/dL
3. Active coronary artery disease
4. Participation in structured exercise (\>3 times per week for 30 minutes or longer)
5. Smoking
6. Medications known to affect muscle metabolism (e.g., beta blockers, corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, anticoagulants)
7. Renal failure (serum creatinine \> 1.5mg/dl)
8. Chronic active liver disease (Bilirubin \> 17mmol/L, AST\>144IU/L, or ALT\>165IU/L)
9. Anti-coagulant therapy (warfarin/heparin)
10. INR \>3
11. Use of systemic glucocorticoids
12. Chronic use of NSAIDS or aspirin
13. Pregnancy or breastfeeding
14. Alcohol consumption greater than 2 glasses/day
15. Hypothyroidism
16. Fish or shellfish allergy

Primary outcomes:
measure: Change in Muscle protein synthesis
timeFrame: Baseline and following 4 months intervention
measure: Change in Muscle mitochondrial function
timeFrame: Baseline and following 4 months intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ian R Lanza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05056142: Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor
Official title: Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.


Eligibility criteria: Inclusion Criteria:

* Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination)
* Aged 18-40 years old
* Single, term pregnant with normal fetal heart rate
* Request neuroaxial analgesia

Exclusion Criteria:

* Parturient who refuses to participate,
* American Society of Anesthesiologists (ASA) physical status \>II,
* Body mass index more than 35 kg/m2
* Severe pre-eclampsia or eclampsia
* Uncontrolled thyrotoxicosis
* Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy)
* Increased intracranial tension due to a space-occupying lesion
* Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery.
* Hypersensitivity to the study drugs
* Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation

Primary outcomes:
measure: The time to perform the block
timeFrame: Intraoperative
Secondary outcomes:
measure: Mean arterial blood pressure (MAP)
timeFrame: Intraoperative
measure: Heart rate (HR)
timeFrame: Intraoperative
measure: Number of participnts with Postoperative nausea and vomiting (PONV)
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT01655342: Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth
Official title: Assessment of the Effectiveness of Biodentine® in Pulpotomies Primary Teeth.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effectiveness of Biodentine® in Pulpotomies Primary Teeth
Keywords: pulpotomy
primary teeth
Biodentine®
formocresol
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy children attending the Pediatric Dentistry Clinic of the Hebrew University-Hadassah School of Dental Medicine in Jerusalem

Brief summary: Clinical and radiographic assessment of Biodentine® as a pulp dressing material for pulpotomy treatment in human primary molars.


Eligibility criteria: Inclusion Criteria:

* one or more primary teeth which requires pulpotomy.

Exclusion Criteria:

* not healthy patients,
* patients with teeth which requires pulpectomy.

Primary outcomes:
measure: Success of the primary molar pulpotomy
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Laurent P, Camps J, About I. Biodentine(TM) induces TGF-beta1 release from human pulp cells and early dental pulp mineralization. Int Endod J. 2012 May;45(5):439-48. doi: 10.1111/j.1365-2591.2011.01995.x. Epub 2011 Dec 22.
Clinical trial NCT06306742: Open-label Placebo in Manual Therapy
Official title: Open-label Placebo in Manual Therapies: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Low Back Pain, Recurrent
Keywords: Placebo
Placebo effect
Open-label trial
Lead sponsor: Studio Osteopatico Busto Arsizio
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the effects of placebo in patients affected by low-back pain.


Eligibility criteria: Inclusion Criteria:

Adult patients (+18 years) who complain of chronic non-specific low back pain for at least 3 months with or without pain exacerbations at the time of recruitment, will be included.

-Patients will need to have a diagnosis of low back pain made by a physician

Exclusion Criteria:

* pathologies such as ankylosing spondylitis, infections, fractures, tumors or metastases.
* Pregnant women
* patients with previous spinal surgery or undergoing cortisone therapy in the 6 months prior to the trial
* diseases that may affect the interpretation of results such as fibromyalgia
* patients currently being treated by other specialists or other manual therapists

Primary outcomes:
measure: Change in Numeric Rating Scale
timeFrame: Change from baseline of numeric rating scale at week 2, 4 and 8.
measure: Adverse effects
timeFrame: through study completion (8 weeks)
Secondary outcomes:
measure: Change in measures of Von Frey filaments
timeFrame: from baseline at week 2,4 and 8.
measure: Changes in algometer measurements
timeFrame: from baseline at week 2, 4 and 8
Other outcomes:
Locations:
city: Saronno
country: Italy
facility: CTFO
state: Varese
Study officials:
References:
Clinical trial NCT01527942: Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients
Official title: Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Pain
Keywords: Pain Management
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2012-02-07
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.


Eligibility criteria: Inclusion Criteria:

* Morbidly Obese and body mass index (BMI) of 35
* Between ages 20-17
* Candidates for Laparoscopic Bariatric Surgery

Exclusion Criteria:

* know hypersensitivity to acetaminophen or opioids
* impairment in liver function
* renal dysfunction
* mental retardation

Primary outcomes:
measure: Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
timeFrame: baseline and 24 hours
Secondary outcomes:
measure: Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours
timeFrame: baseline and 24 hours
measure: Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.
timeFrame: 24 hours after baseline
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital
state: Connecticut
Study officials:
affiliation: Saint Francis
name: Ioannis Raftopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: