louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03729375: The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
Official title: The Effect Of An Anesthetic Procedure On Post Operative Pain Management In Carpal Tunnel Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Postoperative
Carpal Tunnel Syndrome
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal Tunnel Syndrome patients undergoing carpal tunnel release surgery performed by the PI will receive intra-operative injections of bupivacaine (Marcaine). Two groups of patients will be randomly selected and will receive either 10cc or 20cc of injection. Their post-operative pain scores and usage of post-operative pain medication will be recorded and analyzed.

Detailed description: This randomized control trial will be conducted at the USF Department of Orthopaedics at the USF Health Morsani Center after receiving approval from the USF Institutional Review Board. Patients will be evaluated Carpal Tunnel Syndrome and screened as candidates for Carpal Tunnel Release surgery, following the inclusion and exclusion criteria. The Medical Record Number (MRN) will be used to randomly assign into treatment interventions. Group 1 and group 2 will receive 10cc and 20cc of intra-operative intra-carpal tunnel anesthetic injection, respectively. Postoperatively, patients will be prescribed an opioid pain medication in congruence with current standard medical practice. Patients will be contacted at 24-hours, 48-hours, 72-hours, and at 2-week clinic follow-up by research staff and will be evaluated for pain levels through the LIKERT scale and pain management through use of prescribed and supplemental pain medications. All data will be analyzed through SPSS v25.

Eligibility criteria: Inclusion Criteria:

* patient must be undergoing carpal tunnel release surgery performed by PI
* EMG or Ultrasound diagnosed carpal tunnel syndrome

Exclusion Criteria:

* co-musculoskeletal injuries

Primary outcomes:
measure: Change in Pain Level in various stages of the post-operative period
timeFrame: Changes in pain scores at 24 hours, 48 hours, 72 hours, and 2 weeks post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida Department of Orthopaedics
state: Florida
Study officials:
affiliation: USF Orthopaedics
name: Francisco Schwartz-Fernandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03783975: KCNQ1 Cascade Screening
Official title: A Community-Based Approach to Overcoming Barriers to Cascade Screening for Long QT Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Long QT Syndrome
Keywords: Cascade
Screening
Ethical
Legal
Social
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2018-12-21
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objectives of the protocol are to: (1) evaluate the uptake of cascade screening and preventative therapies after the implementation of a simplified screening process and (2) assess proband and family member perspectives about the return of research results and cascade screening for the KCNQ1 Thr224Met variant. The investigators will conduct a mixed methods study in the Old Order Amish community where the KCNQ1 variant is enriched over 100,000-fold compared to other populations. The intervention will offer free, mail-in, saliva-based genetic testing for family members of probands. The rate of uptake of testing and preventative therapy after the intervention is implemented (i.e. when 'simplified' free, mail-in, saliva-based testing was available) will be compared to data from before the intervention (i.e. when 'traditional' $50 blood-based testing was available to family members) when uptake was essentially zero. The primary outcome is the rate of uptake of cascade screening with the intervention ('simplified'). The secondary outcomes include: extent of disclosure of genotype results before and after the intervention, proportion of informed relatives who get screened before and after the intervention, and the uptake of appropriate preventative care (e.g. seeing a cardiologist and/or taking beta-blocker). The tertiary outcomes are demographic characteristics associated with uptake of cascade screening or uptake of preventative therapy. The investigators will also assess qualitative themes surrounding the return of results process and cascade screening using interviews.


Eligibility criteria: Inclusion Criteria:

* KCNQ1Thr224Met proband or first degree family member

Exclusion Criteria:

* Family members who have not been contacted by probands

Primary outcomes:
measure: Percentage of At-risk Family Members Who Underwent Cascade Screening
timeFrame: 18 months
Secondary outcomes:
measure: Extent of Disclosure Determined by Questionnaire
timeFrame: 18 months
measure: Number of Informed Relatives Screened Determined by Questionnaire
timeFrame: 18 months
measure: Number of Participants With an Uptake of Preventative Therapy as Determined by Questionnaire
timeFrame: 18 months
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: University of Maryland Amish Research Clinic
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01827475: Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Official title: Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: musculoskeletal pain
acetaminophen
ibuprofen
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 90
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: The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.

Detailed description: The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.

Eligibility criteria: Inclusion Criteria:

* Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

Exclusion Criteria:

* Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.

Primary outcomes:
measure: Pain Severity
timeFrame: 1 hour
Secondary outcomes:
measure: Need for Rescue Pain Relief
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Stony Brook University
name: Adam J Singer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
Clinical trial NCT06903975: BoTox Into the Sternocleidomastoid Muscles (SCM)
Official title: The Effect of Injection of prabotulinumtoxinA-xvfs (Jeuveau) Into the Bilateral Sternocleidomastoid Muscles on Neck Circumference and Aesthetics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Neck Muscle Issue
Keywords: Neck circumference
Neck aesthetics
Sternocleidomastoid muscles (SCM)
Botulinum injection
PrabotulinumtoxinA-xvfs injection
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Evolus, Inc.
First posted: 2025-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Botulinum toxin injections have been used both in the face and neck for many years. However, injection into the sternocleidomastoid muscle (SCM) has only been done to treat neck spasms. In this study botulinum toxin will be injected into the SCM to determine if this will result in a temporary slimming effect on the neck and produce a more feminine, youthful neck contour.

Detailed description: The specific study objectives are to determine if:

* the neck circumference is decreased at 4 weeks after botulinum toxin (prabotulinumtoxinA-xvfs) injection.
* patients can appreciate a difference in their neck contour, self-confidence, and the way they perceive themselves post-injection via an aesthetics outcome and a neck perception survey.
* injection of the botulinum toxin into the sternocleidomastoid muscle is safe to perform based on adverse events.

Eligibility criteria: Inclusion Criteria:

* Age eligible individual seeking a more feminine neck appearance

Exclusion Criteria:

* Prior neuromodulator injections in the sternocleidomastoid muscles (SCM) within the past year
* Current anticoagulant use
* Body mass index (BMI) \>30
* Anticipation of significant weight gain or loss during the study period (e.g. patients taking or planning to take within the study period a semaglutide medication.)
* Prior allergy to botulinum toxin A
* Currently pregnant or breastfeeding

Primary outcomes:
measure: Neck circumference
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Post injection neck appearance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Newton
country: United States
facility: The Spiegel Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center and The Spiegel Center
name: Jeffrey Spiegel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02955875: Pharmaceutical Care Service in Diabetes
Official title: Impact of Pharmaceutical Care Service for Type 2 Diabetes Mellitus Patients in Korea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Pharmaceutical Services
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: Pusan National University Hospital
First posted: 2016-11-04
Enrollment: 257
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to examine the effectiveness of pharmaceutical care service in the management of poorly controlled type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria: Patients who visit Endocrinology and Metabolism department of Pusan National University Hospital, are with type 2 diabetes mellitus, and meet one of the following criteria

* Who are diagnosed with type 2 diabetes mellitus for the first time
* Who need the education for medication or disease
* Who are with poorly controlled blood glucose
* Who have poor medication adherence
* Who have been hospitalized with diabetes complication or poorly controlled blood glucose
* Whose physician recommend the pharmaceutical care to them

Exclusion Criteria: Patients who meet one of the following criteria

* Who are with gestational diabetes
* Who are not able to respond to questionnaires
* Who are with severe condition such as cerebrovascular disease, mental disorder, and acquired immune deficiency syndrome
* Who are not able to be followed-up during 9 months in Pusan National University Hospital

Primary outcomes:
measure: Medications knowledge at 9 months
timeFrame: 9 months
Secondary outcomes:
measure: HbA1c level at 9 months
timeFrame: 9 months
measure: Random blood glucose level at 9 months
timeFrame: 9 months
measure: Blood pressure at 9 months
timeFrame: 9 months
measure: Cholesterol level at 9 months
timeFrame: 9 months
measure: Proportion of participants taking statins 9 months
timeFrame: 9 months
measure: Proportion of participants managing diabetes complications at 9 months
timeFrame: 9 months
measure: Morisky Medication Adherence Scale at 9 months
timeFrame: 9 months
measure: 5-level version of the EQ-5D at 9 months
timeFrame: 9 months
measure: EQ Visual Analogue Scale at 9 months
timeFrame: 9 months
measure: Problem Areas In Diabetes-Korean questionnaire at 9 months
timeFrame: 9 months
measure: Patient Satisfaction Questionnaire-Korean at 9 months
timeFrame: 9 months
measure: Cost-effectiveness of pharmaceutical care at 9 months
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00748475: Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus
Official title: Countering Stimulus-Induced Alpha-Desynchronization to Treat Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effect of alpha-neurofeedback while subjects listen to a noise on tinnitus.


Eligibility criteria: Inclusion Criteria:

* Duration of Tinnitus \>= 6 months and \<= 20 years
* Subjective Tinnitus

Exclusion Criteria:

* History of neurological or more than mild psychiatric diseases

Primary outcomes:
measure: Reduction of tinnitus distress using the Tinnitus Questionaire
timeFrame: Before the first and after the last session.
measure: Cortical Alpha Power
timeFrame: Before the first and after the last session
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Konstanz
name: Nathan Weisz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Konstanz
name: Thomas Hartmann, Dipl.-Psych.
role: STUDY_CHAIR
References:
Clinical trial NCT04036175: Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.
Official title: Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ICU
Extubation
Non-invasive Ventilation
High-Flow Nasal Oxygen Therapy
Respiratory Effort
Work of Breathing
Tidal Volume
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.


Eligibility criteria: Inclusion Criteria:

* Minimum age: 18 years
* planned extubation decided by the physician in charge of the patient after success of weaning trial
* patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
* Hypoxemia defined by PaO2/FiO2 \< 300 mmHg under mechanical ventilation before extubation

Exclusion Criteria:

* Duration of mechanical ventilation prior to extubation \< 24h
* Contraindication to NIV
* Contraindication to nasogastric tube
* Do-not-reintubated order at time of extubation
* People under legal protection
* Opposition to participate

Primary outcomes:
measure: Patient respiratory effort and tidal volume (Vt)
timeFrame: 1h20
Secondary outcomes:
measure: Respiratory parameters
timeFrame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
measure: Respiratory parameters
timeFrame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
measure: Respiratory parameters
timeFrame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
measure: Respiratory parameters
timeFrame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
measure: Hemodynamic parameters
timeFrame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
measure: Comfort evaluation
timeFrame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
city: Poitiers
country: France
facility: Intensive reanimation
Study officials:
affiliation: Medecine intensive reanimation CHU Poitiers
name: Arnaud W. THILLE, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
Clinical trial NCT03798275: Coffee Consumption and Pregnancy
Official title: The Effect of Coffee Consumption on Fetal Renal Artery Blood Flow and Amniotic Fluid Volume in the Third Trimester of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coffee
Pregnancy
Keywords: amniotic fluid index
caffeine
coffee
oligohydramnios
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-01-09
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coffee, tea, and cocoa contain caffeine, a plant alkaloid. They are frequently consumed during pregnancy. We examined the effect of coffee consumption on fetal renal artery blood flow and amniotic fluid index (AFI) in the third trimester of pregnancy

Detailed description: This cross-sectional study occurred in a tertiary center with volunteer pregnant women who agreed to drink coffee. In healthy pregnant women with isolated borderline oligohydramnios, AFI and fetal renal artery blood flow indices were evaluated before and after coffee consumption. Sixty three patients for the borderline oligohydramnios group (the study group) were included in this study. These patients were compared with 63 healthy pregnant women who had normal amniotic fluid volume (the control group)

Eligibility criteria: Inclusion Criteria:

* Pregnant women with a singleton, uncomplicated pregnancy between the 34th and 37th weeks of gestation were included in this study during routine antenatal examinations

Exclusion Criteria:

* abnormal amniotic fluid volume (AFV), any intake of nutrient or fluid within the 4 hours previous to ultrasonographic examination \[10\], abnormal Doppler blood flow, hypertension, preeclampsia, chromosomal anomaly, intrauterine growth restriction, fetal anomaly, collagen vascular disease, ruptured fetal membranes, and multiple pregnancies.

Primary outcomes:
measure: amniotic fluid index
timeFrame: two hours
measure: fetal renal artery doppler indices
timeFrame: two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri̇
country: Turkey
facility: Yusuf Madendağ
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Kayseri Şehir hastanesi
name: YUSUF MADENDAĞ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02355275: Thera-Band® HEP for LBP Secondary Prevention
Official title: Thera-Band® Based Home Exercise Program for Low Back Pain Secondary Prevention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: Home Exercise
Resistance Exercise
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effectiveness of a Thera-Band based home exercise program (HEP) on LBP and disability 4 weeks post treatment discharge.

Detailed description: The effectiveness of interventions for the treatment of acute and chronic LBP has been extensively studied, but study of the strategies for preventing the progression of acute LBP episodes into chronic back pain is still lacking. Therefore, determining the most effective secondary prevention strategy for the prevention of recurrences of LBP is essential for the reduction of long term disability. The purpose of this study is to determine the effectiveness of a Thera-Band based home exercise program (HEP) on LBP and disability 4 weeks post treatment discharge. A convenience sample of 22 new patients, 18-65 years of age, with current, chronic LBP will be recruited for this study at the discharge visit from care. Exclusionary criteria will include, current pregnancy and the presence of any red flags such as tumor or cancer, vertebral fracture, or infection. Upon agreeing to the study, patients will sign an informed consent, complete a demographics questionnaire, and complete specific outcome measure assessments. The outcome measures will include Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI). Additionally, subjects will be asked to complete a secondary prevention program questionnaire. Following the initial paperwork, all patients will be provided with a Thera-Band® Loop and Band and handout describing the HEP to be performed 3 times a week for 4 weeks. At the conclusion of 4 weeks, a follow-up phone call or email, based on patient preference, will be conducted. The follow-up will include pain, disability, compliance, satisfaction of program of the home program.

Eligibility criteria: Inclusion Criteria:

* current, chronic low back pain
* discharging from care

Exclusion Criteria:

* current pregnancy
* presence of any red flags such as tumor or cancer, vertebral fracture, or infection

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport & Spine Rehab
state: Maryland
Study officials:
References: