louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04091607: Using Music During Lumbar Medial Branch Block Procedure
Official title: An Evaluation of Pain, Anxiety, Desire for Repeat Procedure, and Satisfaction Utilizing Music Therapy for Chronic Low Back Pain Patients During Lumbar Medial Branch Blocks"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Lumbar Spondylosis
Keywords: lumbar medial branch block
chronic back pain
lower back pain
lumbar spondylosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 will listen to Music during the procedure. Group 2 will not hear any music during the procedure
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if music therapy during interventional lumbar medial branch blocks for chronic lower back pain will lower pain scores and anxiety levels, while increasing patient desire for repeat procedure as well as patient satisfaction.

Detailed description: Subjects will be put into 1 of 2 groups, Music or the Control Group (no music). The music group will listen to patient's preferred music on Pandora station broadcast using Headphones or Wireless Earbuds with Tablet or Computer. Hearing impaired patients will have an option of non-earbud headphones. . Earbuds or headphones will be used regardless of music therapy playing. . The control group will be provided earbuds or alternative headphone as well, however, with no music. The sound environment will be standardized for procedure by closing procedure room door and minimizing extraneous sounds (i.e. from equipment, alarms, etc.,).

Eligibility criteria: Inclusion Criteria:

* Age\> or equal to 18
* History of documented chronic lower back pain

Exclusion Criteria:

* Patient refusal
* Deafness (unless corrected with a hearing aid)
* Initial Pain Score \< 3
* Prior Lumbar Medial Branch Blocks/Radiofrequency ablation therapy
* Any woman who is currently pregnant.

Primary outcomes:
measure: Pain Scores with True Visual Analog scale
timeFrame: Day 1 Pre Procedure
measure: Pain Scores with True Visual Analog scale
timeFrame: Day 1 Post Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heather Columbano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321007: Study of Placental Function in Healthy and Pathological Pregnancies
Official title: Study of Placental Function in Healthy and Pathological Pregnancies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 1250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy women delivering at term as well as women with pregnancy complications such as pre-term birth, intrauterine growth restriction, diabetes and obesity will be eligible for the study.

Brief summary: The purpose of this study is to establish a tissue and data repository consisting of samples of human placentas, umbilical cord blood, and maternal blood, collected at the time of delivery. Specimens will be used in cellular, molecular, and functional studies to learn more about changes in placental structure and function, which can result in serious pregnancy complications and determine life-long health by programming the fetus for future metabolic and cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Healthy women delivering at term
* Women with pregnancy complications such as:

  * pre-term birth,
  * intrauterine growth restriction,
  * diabetes, and
  * obesity.

Exclusion Criteria:

* Women:

  * under stress,
  * experiencing pain of labor.
* Pregnancies complicated by other pathologies.

Primary outcomes:
measure: Collecting, processing, and archiving human specimens from 1250 subjects
timeFrame: Specimens will be stored for 50 years in repository
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Thomas Jansson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00104507: Safety and Efficacy of APD356 in the Treatment of Obesity
Official title: A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Serotonin
5-HT2c
Satiety
Obesity
Appetite suppressant
Weight Loss
Overweight
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-03-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.

The purpose of this study is to obtain preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.

Detailed description: This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Eligibility criteria: * Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
* Body Mass Index (BMI) of 30-45 Kg/m\^2.
* Non-smoker
* No concomitant medications
* No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency

Primary outcomes:
measure: Change in body weight
Secondary outcomes:
measure: Safety
measure: Changes in waist circumference, hip circumference and waist/hip ratio
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT06263907: Stellate Ganglion Block for Prevention of Post Mastectomy Depression
Official title: Preemptive Efficacy of Stellate Ganglion Block for Prevention of Post Mastectomy Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mastectomy
Pain, Acute
Pain, Chronic
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 140
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomization into two equal groups using computer-generated random numbers prior to surgery of 70 each; Group S: will receive ipsilateral stellate gangalion block and Group C: will receive no block.
Primary purpose: PREVENTION

Brief summary: Complications after mastectomy include chronic pain and depression.

Detailed description: A mastectomy is surgery could be associated with complications include chronic pain and depression. In female breast cancer patients, the incidence of postoperative depression was 46.55%. Stellate ganglion block had been used for treating post-traumatic stress disorder (PTSD) and depression symptoms even in its prevention. Also, it used in treatment of chronic pain.

Eligibility criteria: Inclusion Criteria:

* Female patients
* Age ranging from 18 to 65 years
* American Society of Anesthesiologists (ASA) no more than II
* Had unilateral cancer breast
* Scheduled to do unilateral modified radical mastectomy

Exclusion Criteria:

* Pregnant female
* Existing Horner syndrome
* Had any neuromuscular disease
* Had allergy to local anesthetics
* History of use of analgesics
* Had any deformity or a previous surgery in the neck or ipsilateral arm or breast
* Had any contraindication to the procedure (coagulation disorders, local infection, sepsis)
* Had any contraindication to the sympathetic blockade (decompensate cardiopulmonary or hemodynamic disorders)
* History of psychotic disorder including depression, bipolar disorder or personality disorder
* Patient with Beck Depression Inventory (BDI) score more than 13

Primary outcomes:
measure: incidence of postmastectomy depression
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: incidence of postmastectomy depression
timeFrame: 3 months postoperatively
measure: the need for postoperative antidepressant
timeFrame: during the first 6 months postoperatively
measure: acute postoperative pain at the incision site (breast and the axilla)
timeFrame: every 12 hour for the first 48 hour recorded
measure: chronic postmastectomy pain at the incision site
timeFrame: at 3 and 6 months postoperatively
measure: incidence of nausea and vomiting
timeFrame: during first 3 postoperative days
measure: Functional pain in the ipsilateral shoulder
timeFrame: during the first 6 months postoperatively
measure: Any complications related to stellate ganglion injection
timeFrame: within 1 day postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Maha
Study officials:
References:
Clinical trial NCT00602407: Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions
Official title: A Single Dose, Randomized, Two-Period, Two-Treatment, Crossover Bioequivalency Study of Cilostazol 50 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Cilostazol or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04350307: Comparison of Intravascular Uptake and Pain Perception During Epidural Injection Using 22 Gauge vs 25 Gauge Needle
Official title: Differential Rates of Intravascular Uptake and Pain Perception During Lumbosacral Transforaminal Epidural Steroid Injection Using a 22-gauge Needle Versus 25-gauge Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Needle Injury
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Rothman Institute Orthopaedics
First posted: 2020-04-17
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a prospective single blind randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral epidural steroid injection in regards to intravascular uptake and pain perception. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain.

Detailed description: Inadvertent intravascular injection has been suggested as the most probable mechanism behind serious neurological complications during transforaminal epidural steroid injections. There is the notion that a smaller gauge needle may lead to less intravascular uptake and less pain. The aim of the study was to quantify the difference between a 22-gauge needle and 25-gauge needle during lumbosacral transforaminal epidural steroid injection in regards to intravascular uptake and pain perception.

Eligibility criteria: Inclusion Criteria:

1. patients with low back pain and/or radicular pain,
2. patients scheduled for lumbosacral TFESI.

Exclusion Criteria:

1. patients with contrast/local anesthetic allergy,
2. patients with pregnancy, coagulopathy, systemic infection, and inability to provide informed consent,
3. vulnerable patient population including prisoners,
4. patients with severe anxiety,
5. patients with prior lumbar surgery,
6. age \<18 years old, and
7. Body Mass Index (BMI) \> 40.

Primary outcomes:
measure: Intravascular Uptake
timeFrame: During the procedure
Secondary outcomes:
measure: Patient Reported Pain
timeFrame: During the procedure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Robin Raju, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raju R, Mehnert M, Stolzenberg D, Simon J, Conliffe T, Gehret J. Differential rates of intravascular uptake and pain perception during lumbosacral epidural injection among adults using a 22-gauge needle versus 25-gauge needle: a randomized clinical trial. BMC Anesthesiol. 2020 Sep 3;20(1):222. doi: 10.1186/s12871-020-01137-0.
Clinical trial NCT06763107: Validation and Inverse Analysis of The Athletic Shoulder Test (ASH).
Official title: Validation and Inverse Analysis of The Athletic Shoulder Test (ASH): Reliability of a Novel Upper Body Isometric Strength Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Sports Physical Therapy
Keywords: Shoulder Pain; Isometric Strength; Muscle Strength Imbalance; Sports Medicine; Rehabilitation
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 21
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Validation of isometric shoulder strength tests (ASH and IASH) in high-performance swimmers.
Primary purpose: DIAGNOSTIC

Brief summary: To validate both the Athletic Shoulder (ASH) test, conducted on rugby players, and its inverse, the Inverse Athletic Shoulder (IASH) test, for swimmers. This involves assessing the strength relationship between shoulder flexion and extension at three different adduction angles (180º, 135º, 90º) to identify potential injuries associated with these imbalances.


Eligibility criteria: Inclusion Criteria:

* High-performance swimmers.
* Aged between 14 and 18 years.
* No acute injuries in the cervical or scapular region.
* Ability to perform the ASH and IASH tests without compensatory movements.

Exclusion Criteria:

* Acute injuries in the cervical or scapular region.
* Inability to maintain proper positioning during the tests due to lack of adequate mobility or strength.
* Refusal to sign informed consent (or legal guardian's consent for minors).

Primary outcomes:
measure: Intraclass Correlation Coefficient (ICC) for ASH Test
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
measure: Intraclass Correlation Coefficient (ICC) for IASH Test
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
measure: Coefficient of Variation (CV) for ASH and IASH Tests
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
measure: Minimum Detectable Change (MDC) for ASH and IASH Tests
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
measure: Force Ratios Between ASH and IASH Tests
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
measure: Comparison of Shoulder Strength Between Preferred and Non-Preferred Breathing Sides
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
measure: Evaluation of Test Fatigue and Its Impact on Reliability
timeFrame: Measured at two time points: baseline (Day 0) and follow-up (Day 2).
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Pablo
Study officials:
References:
Clinical trial NCT00424307: Bilateral Cochlear Implant Benefit in Young Children
Official title: Development of Auditory Skills in Young Deaf Children With Bilateral Cochlear Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hearing Loss
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in two different surgeries with the initial fitting of the devices separated by no more than six months.


Eligibility criteria: Inclusion Criteria:

* Profound bilateral hearing loss
* Have independently elected to undergo bilateral implantation of Advanced Bionics HiResolution Bionic Ear System
* Age at implant: 12-36 months
* No previous cochlear implant use
* English as the primary language spoken in the home
* Parental willingness to follow study protocol

Exclusion Criteria:

* Deafness secondary to meningitis
* Presence of other conditions that could affect study participation

Primary outcomes:
measure: Assessment of Speech Perception Skills
timeFrame: Various time points
Secondary outcomes:
measure: Health-Related Quality of Life and Assessment of Communicative Performance
timeFrame: Various time points
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's HEAR Center
state: Alabama
city: Los Angeles
country: United States
facility: House Ear Institute
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Tampa
country: United States
facility: Tampa Bay Hearing and Balance Center
state: Florida
city: Chicago
country: United States
facility: The Children's Memorial Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Hospital
state: Michigan
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: St. Louis
country: United States
facility: Washington University of St. Louis
state: Missouri
city: Omaha
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
city: New York
country: United States
facility: New York University
state: New York
city: Dallas
country: United States
facility: Dallas Otolaryngology Associates
state: Texas
city: Edmonton
country: Canada
facility: Glenrose Rehab Hospital
state: Alberta
Study officials:
affiliation: Advanced Bionics
name: Mary Joe Osberger, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04913207: Comprehensive CT-guided vs Echo-fluoroscopy-guided Strategy in the Left Atrial Appendage Occlusion
Official title: Comparison of Comprehensive CT-guided Versus Traditonal Echo-fluoroscopy-guided Strategy in the Implantation of the LAmbre Left Atrial Appendage Occlusion, a Prospective, Multi-center and Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiology
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 310
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: Percutaneous left atrial appendage occlusion (LAAO) is an increasingly used alternative to oral anticoagulation in patients with nonvalvular atrial fibrillation (AF). Transesophageal echocardiography (TEE) and fluoroscopy were used to measure the maximal diameters of LAA. However, the LAA maximal diameters measured on Two dimensional (2D) views could be limited due to the morphology of LAA varies with each individua. Three dimension computed tomography angiography technology (3D-CTA) is based on cardiac computed tomography angiography (CCTA). The 3D-CTA technology provides an innovative measuring method of LAA to guide the selection of device size, and the best fluoroscopy view to implant device. This measuring method and guideline have never been reported and its role in LAAO is uncertain

Detailed description: The PERIVISION-LAAO study will be a prospective, multi-center and randomized trial designed to investigate the effect and safety of perimeter obtained by 3D-CTA versus diameter obtained by traditional echo-fluoroscopy in guidance of device size selection in the procedure of LAAO. It will enroll 310 patients with nonvalvular atrial fibrillation (AF) who will be randomized at 1:1 ratio into the perimeter guidance group or diameter guidance group. The major effect endpoint will be the success at first device selected in procedure, and the major safety outcome will be the incidence of pericardial effusion during the procedure and the follow-up period of 2 months after the procedure.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of atrial fibrillation Disease
* Age \>18years
* CHA2DS2-VASc scores ≥ 2
* And at least one of the following indications: (a) HAS- BLED scores ≥ 3; (b) intolerance to long-term OAC; (c) stroke, TIA or thromboembolism even under OAC treatment

Exclusion Criteria:

* GFR \<50 mL/min/1.73 m2
* Thrombus in LA and LAA

Primary outcomes:
measure: the rate of success at first device selected
timeFrame: In the procedure of LAAO
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University, School of Medicine, Affiliated Ren Ji Hospital
name: HJ LUO
role: STUDY_CHAIR
References: