louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01527175: Ultrasound-guided Subclavian Venous Catheterization in Children
Official title: Comparision of Ultrasound-guided Supraclavicular and Infraclavicular Approach for Central Venous Catheterization in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subclavian Venous Catheterization in Children
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 98
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. The investigators compared the success rate, number of attempts, time tocatheterization, and complication.


Eligibility criteria: Inclusion Criteria:

* central venous lines required patients
* children \< 10 yr of age

Exclusion Criteria:

* inadequate ultrasound visualization of the subclavian vein

Primary outcomes:
measure: The duration for susscessful placement of needle into subclavian vein
timeFrame: within 20 minutes
Secondary outcomes:
measure: The number of attempt for susscessful placement of needle into subclavian vein.
timeFrame: within 20 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
citation: Byon HJ, Lee GW, Lee JH, Park YH, Kim HS, Kim CS, Kim JT. Comparison between ultrasound-guided supraclavicular and infraclavicular approaches for subclavian venous catheterization in children--a randomized trial. Br J Anaesth. 2013 Nov;111(5):788-92. doi: 10.1093/bja/aet202. Epub 2013 Jun 10.
Clinical trial NCT04864275: Personalized Prediction of Persistent Postsurgical Pain
Official title: Personalized Prediction of Persistent Postsurgical Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Postoperative
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 2750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are 18 to 75 years of age and candidates for major surgery at Barnes-Jewish Hospital (expected surgery duration \>1h, and expected overnight admission to the hospital) will be approached for consent to this study. Participants will be recruited for participation in the study during their initial preoperative visit to the Center for Perioperative Assessment and Planning (CPAP).

Brief summary: P5 is planned as a prospective observational study, collecting evidence-based perioperative data on patient history and demographics, physical function, cognitive measures, psychological, and biological markers associated with increased pain susceptibility, and psychophysical measures of pain processing.

The study will use daily ecologic momentary assessment (EMA) of physical and emotional parameters, and collect data on perioperative events.

Follow up will occur 3 months and 6 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Adults age 18-75 who are candidates for major surgery (expected surgery duration \>1 hour, and expected overnight admission to the hospital)
* Access to a smartphone

Exclusion Criteria:

* Participants who do not speak English

Primary outcomes:
measure: Persistent Postsurgical Pain (PPSP)
timeFrame: up to 7 months following consent
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
Study officials:
affiliation: Associate Professor
name: Simon Haroutounian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016 Mar 1;94(3):201-209F. doi: 10.2471/BLT.15.159293.
citation: Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.
citation: Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Clinical trial NCT06101875: Health Coaching for Patients Waiting for Hip or Knee Replacements
Official title: Feasibility of Targeted Health Coaching for Patients With Low Activation Waiting for Total Hip or Total Knee Replacements
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Osteo Arthritis Knee
Lead sponsor: Sheffield Hallam University
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2023-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised controlled feasibility study of a health coaching intervention targeting people on the waitlist for hip or knee replacement surgery with low patient activation.

Detailed description: Determine the feasibility of recruitment and retention to the trial. Evaluate the acceptability of research procedures and outcome measures. Explore the impact of trial participation through patient activation, self-reported health outcomes and interviews.

Eligibility criteria: Inclusion Criteria:

* On the waitlist for total hip or total knee replacement surgery
* PAM level 1 or 2

Exclusion Criteria:

* Current participation in care with a focus on self-management education
* PAM Level 3 or 4

Primary outcomes:
measure: Recruitment Rates
timeFrame: 4 weeks
measure: Retention Rates
timeFrame: 12 weeks
measure: Acceptability of intervention
timeFrame: 12 weeks
measure: Competition rates
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in patient activation
timeFrame: 12 weeks
measure: Change in quality of life
timeFrame: 12 weeks
measure: Change in pain score
timeFrame: 12 weeks
measure: Change in physical activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
state: South Yorkshire
Study officials:
affiliation: Sheffield Hallam Unviersity
name: Tom Maden-Wilkinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05429775: In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
Official title: A Single Part, Four Period Sequential, Open Label Study Designed to Evaluate the In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2022-06-23
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.

Detailed description: Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. For each treatment period, subjects will be admitted to the clinical unit on the evening prior to IMP administration (Day -1) and will fast overnight for a minimum of 8 h. On the morning of Day 1, subjects will receive IMP in the fasted state and will remain on site until 24 h post-dose. Following Period 2, there will be an interim analysis and review of safety and scintigraphy data from dosed regimens in order to determine which formulations will be used in subsequent periods. A follow-up phone call will take place 3 to 5 days post-final dose to ensure the ongoing wellbeing of the subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged 30 to 65 years
* Body mass index 18.0 to 32.0 kg/m2

Exclusion Criteria:

* None

Primary outcomes:
measure: Total oesophageal transit time
timeFrame: During procedure
measure: Time at which 10% radiolabel administered has arrived in the oesophagus from the mouth (T10%) (min)
timeFrame: During procedure
measure: Time at which 50% radiolabel administered has arrived in the oesophagus from the mouth (T50%) (min)
timeFrame: During procedure
measure: Time at which the amount of radiolabel present in the oesophagus peaks (Tmax) (min)
timeFrame: During procedure
measure: Time at which 90% of the radiolabel present at Tmax has left the oesophagus (T90%) (min)
timeFrame: During procedure
measure: Total amount of radiolabel present in the oesophagus and the three regions over time
timeFrame: During procedure
Secondary outcomes:
measure: Number of adverse events
timeFrame: throughout the study, approximately 13 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Sandoz Investigative Site
state: England
Study officials:
affiliation: Sandoz
name: Sandoz
role: STUDY_DIRECTOR
References:
Clinical trial NCT04743375: Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
Official title: Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Heal
Wound Surgical
Donor Site Complication
Keywords: Wound dressing
Sericin
Collagen
Split-thickness skin graft donor site (STSG donor site)
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-02-08
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 examine the efficacy and safety of sericin dressing with collagen in STSG donor site treatment comparing with Bactigras®. Around 30 patients will be enrolled in this study.

Detailed description: Wounds are a public health problem found worldwide that associated with both clinical and economic burdens. Although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development.

The sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of each patient will be divided into two equal areas. Each area will be randomly allocated into sericin dressing with collagen group or control group (Bactigras®). The outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing Bactigras®.

Eligibility criteria: Inclusion Criteria:

* Patients who have STSG donor site wounds on the thigh area
* Age more than 18 years old
* The split-thickness skin graft is harvested for the first time at the investigated area.
* Patients who are able to communicate with the Thai language
* Willingness to participate

Exclusion Criteria:

* Patient with a mental disorder or immunocompromised diseases
* Patients who cannot or not willing to follow the protocol
* Known sensitivity or allergy to sericin, chlorhexidine, and collagen
* Pregnancy or lactation

Primary outcomes:
measure: Time to complete healing
timeFrame: 42 days
Secondary outcomes:
measure: Pain score
timeFrame: 42 days
measure: Incidence of infection
timeFrame: 42 days
measure: Incidence of adverse effect
timeFrame: 42 days
measure: Vancouver scar scale (VSS)
timeFrame: 6 months
measure: Patient scale of Patient and observer scar scale (POSAS)
timeFrame: 6 months
measure: Erythema level
timeFrame: 6 months
measure: Melanin level
timeFrame: 6 months
measure: Trans-epidermal water loss (TEWL)
timeFrame: 6 months
measure: Skin hydration
timeFrame: 6 months
measure: Skin elasticity
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
name: Pornanong Aramwit, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06811675: The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
Official title: The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Carbon Monoxide Poisoning
Delayed Neurocognitive Sequelae
Keywords: Carbon Monoxide Poisoning
Dexamethasone
N-acetylcysteine
Delayed Neurocognitive Sequelae
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 128
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: Background and Aim: Carbon monoxide (CO) poisoning is a significant public health issue that can cause delayed neuropsychological sequelae (DNS). DNS mechanisms involve oxidative stress, inflammation, and immune injury. Although hyperbaric oxygen therapy is widely used, its efficacy in preventing DNS remains inconclusive. Preclinical and retrospective studies suggest that Dexamethasone (anti-inflammatory and immunosuppressive) and N-acetylcysteine (antioxidant) may reduce DNS risk. This study hypothesizes that their combination can effectively prevent DNS.

Methods: This prospective pre-post intervention study will enroll CO poisoning patients into treatment (Dexamethasone + N-acetylcysteine) and control groups. The primary outcome is the incidence of DNS within six weeks post-treatment.

Objective: To determine whether combining Dexamethasone and N-acetylcysteine reduces the incidence of DNS following CO poisoning.


Eligibility criteria: Inclusion Criteria:

* History and clinical symptoms consistent with CO poisoning (initial blood carboxyhemoglobin (COHb) levels \>5%, or \>10% for smokers).

Exclusion Criteria:

* Concurrent use of other potentially lethal toxins. Severe trauma or burns that could be fatal. No spontaneous heartbeat or blood pressure before arrival. Poisoning time exceeding 24 hours before hospital arrival. Minors (under 18 years of age). Pregnant women. Patients or their families refuse to sign the consent form. Contraindications for the use of Dexamethasone or N-acetylcysteine (such as severe allergies) or when the physician assesses the risks outweigh the benefits.

Primary outcomes:
measure: Number of participants with delayed neurological sequelae following carbon monoxide exposure, as assessed by clinical evaluation
timeFrame: 2 weeks, 6 weeks, 3 months
Secondary outcomes:
measure: Number of participants with cognitive impairment following carbon monoxide exposure, as assessed by the Mini-Mental State Examination (MMSE)
timeFrame: 2 weeks, 6 weeks, 3 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT06350175: Emergency Department Management of Tobacco Use Disorder
Official title: Emergency Department Based Management of Tobacco Use Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Tobacco Use Disorder
Tobacco Use Cessation
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.


Eligibility criteria: Inclusion Criteria:

* Current daily use cigarettes greater than or equal to ½ pack per day
* Stable for discharge from the ED
* Able and willing to complete telephone/electronic follow up at scheduled intervals
* Reported English speaking

Exclusion Criteria:

* Patients enrolled in specific health insurance plans (PEIA, The Health Plan or Medicaid medical insurance)
* WVU students
* Medically unstable patients
* Patients with clinical decompensation or who are admitted to the hospital
* Patients who are discharged to residential treatment facilities for detoxification
* Uncontrolled psychiatric disorder or psychiatric emergency
* Individuals who are unable to provide consent
* Incarcerated individuals
* Language barrier
* Currently pregnant or attempting to become pregnant
* Presenting for evaluation of sexual assault
* Known allergy or previous intolerance to nicotine replacement therapy

Primary outcomes:
measure: Percentage of Continued Abstinence Rate (2 weeks)
timeFrame: 2 Weeks post initial dose
measure: Percentage of Continued Abstinence Rate (1 month)
timeFrame: 1 Month post initial dose
measure: Percentage of Continued Abstinence Rate (3 months)
timeFrame: 3 Months post initial dose
measure: Patient Health Questionnaire 2 (Baseline)
timeFrame: Baseline
measure: Patient Health Questionnaire 2 (3 months from baseline)
timeFrame: 3 months from baseline
measure: Heaviness of Smoking Index (Baseline)
timeFrame: Baseline
measure: Heaviness of Smoking Index (3 months from baseline)
timeFrame: 3 months from baseline
measure: Richmond Test (Baseline)
timeFrame: Baseline
measure: Richmond Test (3 months from baseline)
timeFrame: 3 months from baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West Virginia University
name: Bradley End
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06812975: Paceport Swan-Ganz Data Collection Study
Official title: Early Identification of Right Ventricular Dysfunction and Failure in Cardiothoracic and Liver Surgical Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: RV Dysfunction
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation

Brief summary: In association with Edwards LifeSciences, the study will aim to develop an algorithm based on right heart (right atrial, right ventricular and pulmonary artery) waveforms for the early detection of RV dysfunction in cardiothoracic and liver surgery patients at UMMC. This is a prospective, non-interventional, observational study.


Eligibility criteria: Inclusion Criteria:

1. Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
2. Participate in the Informed Consent process and sign/date the approved informed consent forms
3. Projected to receive Swan-Ganz paceport catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

Exclusion Criteria:

1. Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
2. Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
3. Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
4. Patients unable to consent to participating in the study
5. Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery
6. Patients under the age of 18 years old
7. Patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy
8. Patients allergic to FORE-SIGHT Elite sensor adhesive
9. Patients with latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Primary outcomes:
measure: Arterial waveform
timeFrame: 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Tjorvi E Perry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212975: Arthrocentesis Followed by Prolotherapy
Official title: TMJ Lavage Followed by Dextrose Prolotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TMJ Pain
Keywords: tmj
pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: we will do tmj joint lavage and followed by dextrose injection

Detailed description: Two groups of patients one group will receive lavage with saline and other group will receive lavage then dextrose injection

Eligibility criteria: Inclusion Criteria:

* tmj painful joints patients healthy patients disk displacement with reduction

Exclusion Criteria:

* patients previously treated males young age group

Primary outcomes:
measure: pain scores
timeFrame: 3 months
measure: Maximum mouth opening measured in millimeter 36mm=normal, less than 36mm=worse
timeFrame: 3 months
Secondary outcomes:
measure: Change in pain symptoms measured by visual analogue scale
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Atef Abd El H Fouda
role: PRINCIPAL_INVESTIGATOR
References: