louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06008002: Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy
Official title: Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Laparoscopic Cholecystectomy
Regional Anesthesia
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, single-blind, observational study
Primary purpose: TREATMENT

Brief summary: Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

Detailed description: In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

Eligibility criteria: Inclusion Criteria:

* laparoscopic cholecystectomy surgery
* Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

Exclusion Criteria:

* Uncontrolled Arterial Hypertension
* Uncontrolled Diabetes Mellitus,
* Mental retardation ,
* Antidepressant use
* Metabolic disorders,
* Bleeding diathesis
* Patients with a body mass index above 30.

Primary outcomes:
measure: NRS
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: tramadol consumption
timeFrame: Postoperative 24 hours
measure: side effect profile scores
timeFrame: Postoperative 24 hours
measure: additional analgesic use
timeFrame: Postoperative 24 hours
measure: pinprick test
timeFrame: Postoperative 24 hours
measure: Ramsay Sedation Scale
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02404402: LED Treatment to Improve Cognition and Promote Recovery in TBI
Official title: Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Posttraumatic Stress Disorder
Keywords: Traumatic Brain Injury
Light Emitting Diodes
Cognition
Neuromodulation
PTSD
Neurorehabilitation
Veterans
Sleep
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-03-31
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

Detailed description: The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
* Meets criteria for mild TBI
* LOC of 30 min or less
* Age: 21-55
* Primary language is English

Exclusion Criteria:

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to TBI
* Hearing or vision impairment

Primary outcomes:
measure: Cognitive Functioning_Attention/Executive
timeFrame: Eight Weeks
measure: Cognitive Functioning_Learning/Memory
timeFrame: Eight weeks
Secondary outcomes:
measure: Neuropsychiatric Status/Mood
timeFrame: Eight weeks
measure: Neuropsychiatric status/PTSD
timeFrame: Eight weeks
measure: Neuropsychiatric status/Sleep
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Yelena Bogdanova, PhD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03222102: Ventral Hernia Prevention After Liver Transplantation
Official title: Ventral Hernia Prevention After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventral Hernia
Liver Transplantation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic, fully resorbable mesh "Phasix" in the course of liver transplantation.

Patients will be randomized in a 1:1 ratio to receive either Phasix mesh or standard surgery without the use of Phasix.

Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

Detailed description: Ventral hernia is a frequently occurring complication following liver transplantation, with a reported risk in the literature ranging from 5% to 25%.

This study aims to evaluate if the risk of developing ventral hernia after liver transplantation can be reduced through the prophylactic implantation of a synthetic mesh "Phasix" in the course of liver transplantation.

PHASIX™ Mesh is a fully resorbable mesh implant prepared from poly-4-hydroxybutyrate (P4HB). Absorption of the mesh material occurs within 12 to 18 months.

Patients will be randomized in a 1:1 ratio to receive either Phasix mesh in the course of liver transplantation or standard surgery without the use of Phasix.

Ultra-sound examinations of the wound area will be performed 14 days, 3, 6 and 12 months after liver transplantation. Furthermore, presence of infections, seroma, pain and other problems in the wound area will be assessed.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* First transplantation
* Signed Informed Consent

Exclusion Criteria:

* Combined transplantation
* Revisions after liver transplantation
* Patients who already received laparotomy or transverse upper laparotomy (longer than 15 cm)
* Preexisting abdominal wall hernia except umbilical hernia after liver transplantation
* Pregnant/lactating women
* Known allergies to tetracycline hydrochloride and kanamycin sulfate

Primary outcomes:
measure: Incidence of ventral hernia
timeFrame: 12 months after liver transplantation
Secondary outcomes:
measure: Infections
timeFrame: 12 months after liver transplantation
measure: Wound healing disorders
timeFrame: 12 months after liver transplantation
measure: Seroma
timeFrame: 12 months after liver transplantation
measure: Hematoma
timeFrame: 12 months after liver transplantation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz; Klin. Abteilung für Transplantationschirurgie
Study officials:
References:
Clinical trial NCT05270902: Haemoadsorption During Heart Transplantation
Official title: Effect of Haemoadsorption During Cardiopulmonary Bypass on Patients After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Transplantation
Keywords: Heart Transplantation
Cytosorb
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, single-blinded, randomized, controlled trial
Primary purpose: TREATMENT

Brief summary: To investigate whether the use of haemoadsorption (HA) on cardiopulmonary bypass during heart transplantation (HTX) has an effect on circulating cytokine levels for the first 120 hours after HTX and induces a decreased inflammatory response, increased anti-inflammatory response or immunosuppressive response. Additionally, the influence of HA on primary graft dysfunction, postoperative cerebral dysfunction, postoperative fluid accumulation, renal dysfunction, duration of mechanical ventilation, length of ICU-stay and 30-day mortality should be investigated


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing heart transplantation

Exclusion Criteria:

* Declined informed consent
* Age \< 18 years#
* Receiving antileukocyte drugs
* Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
* DCD
* Ex-vivo perfusion

Primary outcomes:
measure: Difference in maximal cytokine peak levels (IL-1β, IL-6, IL-33, TNF-α, IL-10)
timeFrame: 5 days
Secondary outcomes:
measure: Difference of immunosuppression (TTV)
timeFrame: 30days
measure: Difference of immunosuppression (sST2)
timeFrame: 30days
measure: primary graft dysfunction score
timeFrame: 7 days
measure: 30-day mortality
timeFrame: 30 days
measure: Mechanical Ventilation
timeFrame: up to 4 weeks
measure: Delirium
timeFrame: 5 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Divison of Cardiac Thoracic Vascular Anaesthesia and Intensive Care, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin H. Bernardi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04142502: Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia
Official title: Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Autonomic Nervous System
Keywords: spinal anesthesia
autonomic nervous system
dexmedetomidine
propofol
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ilsung Pharmaceuticals CO.,LTD.
First posted: 2019-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Propofol group: propofol infusion as sedation drug Dexmedetomidine group: dexmedetomidine infusion as sedation drug
Primary purpose: OTHER

Brief summary: Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system, but the exact effects are not well known. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia.

Detailed description: Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system but the exact effects are not well known. Moreoever, the effect of spinal anesthesia combined with sedation agent on autonomic nervous system has not been evaluated. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia. The current study is prospective randomized pilot study. Patients are assigned to propofol group and dexmedetomidine group. Using electrocardiaogram analysis, the change of autonomic nervous system will be measured from preoperative to end of surgery.

Eligibility criteria: Inclusion Criteria:

* age 20\~60 years old
* Scheduled lower extremity surgery under spinal anesthesia

Exclusion Criteria:

* Arryhthmia
* Uncooperative patients
* Diabetes
* On medication: beta blocker, psychiatric medicine
* Thyroid function abnormality

Primary outcomes:
measure: Serial heart rate variability
timeFrame: 40 minutes (before entering the operating room ~ 20 minutes after starting sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: In Kyong Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03768102: Comparison of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit
Official title: Comparative Study of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain Measurement
Acute Pain
Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-07
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: An adult patient who has been transferred to the recovery room after receiving general anesthesia

Brief summary: In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation is clinically important and challenging in PACU. The pain evaluation tool should be simple and easy to understand for accurate assessment. Among the most commonly used pain assessment methods are numerical rating scale(NRS), visual analogue scale(VAS) and verbal rating scale(VRS). These three methods have proved valid for clinical situations in many studies. VRS appears to be easier to understand than the other two methods for patients in PACU. The purpose of this study is to compare NRS and VRS in PACU patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent general anesthesia
* The American Society of Anesthesiologists(ASA) physical status classification system : class 1, 2, 3

Exclusion Criteria:

* The American Society of Anesthesiologists(ASA) physical status classification system : class 4, 5

Primary outcomes:
measure: Pain measurement by the numerical rating scale
timeFrame: 5 minutes after transferred into the postanesthesia care unit
measure: Pain measurement by the numerical rating scale
timeFrame: 20 minutes after transferred into the postanesthesia care unit
measure: Pain measurement by the numerical rating scale
timeFrame: 40 minutes after transferred into the postanesthesia care unit
measure: Pain measurement by the verbal rating scale
timeFrame: 5 minutes after transferred into the postanesthesia care unit
measure: Pain measurement by the verbal rating scale
timeFrame: 20 minutes after transferred into the postanesthesia care unit
measure: Pain measurement by the verbal rating scale
timeFrame: 40 minutes after transferred into the postanesthesia care unit
measure: nonresponse rate of the numerical rating scale
timeFrame: 1 year
measure: nonresponse rate of the verbal rating scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
state: Select
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02823002: Pain Perception: Lidocaine Rate/Temp/Buffer
Official title: The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria: Inclusion Criteria:

* Subjects who are undergoing dermatologic procedures.
* Subjects ages 18-89 year old.
* The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.

Exclusion Criteria:

* Subjects who are allergic to lidocaine.
* History of bleeding tendency or coagulopathy.
* Pregnant or lactating.
* Active skin disease or skin infection in the treatment area.
* Unable to understand the protocol or give informed consent.
* Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.

Primary outcomes:
measure: Pain on a Visual Analog Scale (VAS)
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03930602: Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165
Official title: An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-04-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)


Eligibility criteria: Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
* Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
* Any major surgery within 4 weeks of study drug administration
* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986165
timeFrame: 10 days
measure: AUC(0-T) of BMS-986165
timeFrame: 10 days
measure: AUC(INF) of BMS-986165
timeFrame: 10 days
Secondary outcomes:
measure: Fluvoxamine steady-state plasma concentrations
timeFrame: 10 days
measure: Percentage of participants with Adverse events (AEs)
timeFrame: From screening up to end of drug treatment (Day 13)
measure: Percentage of participants with Serious Adverse events (SAEs) and Death
timeFrame: From screening up to end of drug treatment (Day 13)
measure: Percentage of participants with Adverse events (AEs) leading to discontinutation
timeFrame: From screening up to end of drug treatment (Day 13)
measure: Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs
timeFrame: From screening up to end of drug treatment (Day 13)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Plc (PRA Health Sciences)
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: