louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06976320: Deep Rectus Sheath Block for Laparoscopic Cholecystectomy
Official title: Deep Rectus Sheath Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Anesthesia
Postoperative Pain
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Postoperative pain after laparoscopic cholecystectomy can be considerable. Regional techniques such as erector spinae plane (ESP) block or transversus abdominis plane (TAP) block may be suitable for patients at increased risk of postoperative pain. The deep rectus shaeth block is a novel block which is a modified version of the conventional rectus sheath block. It was reported in a few case reports that, it may be used for postoperative analgesia in patients undergoing laparoscopic cholecystectomy. The aim of this study is to investigate the postoperative analgesic efficacy of deep rectus sheath block in patients undergoing laparoscopic cholecystectomy.

Detailed description: Patients scheduled for elective laparoscopic gastrectomy will be separated into 2 groups: Control Group and Deep Rectus Sheath Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in Deep Rectus Sheath Block Group will be performed Deep Rectus Sheath Block at the end of the surgery, along with patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, numaerical rating scale scores, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* Patients with American Society of Anesthesiology (ASA) physical status I-II
* Patients scheduled for a laparoscopic cholecystectomy

Exclusion Criteria:

* Allergy to local anesthetics
* Coagulopathy
* Skin infection at the deep rectus sheath block area
* Advanced hepatic or renal failure
* Chronic pain syndromes
* Alcohol or drug abuse
* Severe pulmonary and/or cardiovascular disease
* Psychiatric disorders

Primary outcomes:
measure: Morphine consumption
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Postoperative numerical rating scale scores
timeFrame: Postoperative 24 hours
measure: Rescue analgesic drug requirement
timeFrame: Postoperative 24 hours
measure: Incidence of postoperative nausea and vomiting
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye University Hospital
Study officials:
References:
Clinical trial NCT03342820: Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients
Official title: Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity, Muscle
Muscle Fatigue
Gait, Hemiplegic
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the amount of co-contractions of this last with the hamstrings during a maximal isometric flexion movement in hemiparetic stroke patients.

The effect of such a protocol on gait parameters and spasticity of the quadriceps will be evaluated also.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80y
* Hemiparesis after a first-ever stroke \> 3 months
* Spasticity of the quadriceps muscle
* Quadriceps strength at least at 3/5 (MRC testing)
* Subject able to walk at least 2min without rest
* Informed consent
* Social security affiliation

Exclusion Criteria:

* Severe comprehension troubles (language, cognitive or psychiatric disorders)
* History of previous stroke, locomotor or other neurological disorders
* Locomotor troubles affecting the paretic arm
* Contraindication to efforts : cardiac insufficiency, severe aortic valvular stenosis, recent heart failure, non treated high blood pressure, severe peripheral arterial disease
* Pregnancy or breastfeeding
* Adult subject to guardianship

Primary outcomes:
measure: Cocontraction Index (CCI) between the rectus femoris and the semitendinosus
timeFrame: one day
Secondary outcomes:
measure: Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle
timeFrame: one day
measure: Agonist Recruitment Index of the semitendinosus
timeFrame: one day
measure: Isometric peak knee flexion torque
timeFrame: one day
measure: Spasticity of the quadriceps
timeFrame: one day
measure: spatio-temporal gait parameters at comfortable speed
timeFrame: one day
measure: spatio-temporal gait parameters at comfortable speed
timeFrame: one day
measure: spatio-temporal gait parameters at comfortable speed
timeFrame: one day
measure: Isometric peak knee extension torque
timeFrame: one day
measure: 10 metre walk test (10MWT)
timeFrame: one day
measure: 2 minute walk test (2MWT)
timeFrame: one day
measure: perceived exertion at the end of the 2MWT (Borg Scale 6-20)
timeFrame: one day
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Swynghedauw, CHU
Study officials:
affiliation: University Hospital, Lille
name: Etienne Allart, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626620: Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma
Official title: Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Exacerbation of Asthma
Keywords: Asthma
intravenous
magnesium sulfate
terbutaline
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
Collaborators: name: Nishtar Medical University
First posted: 2024-10-04
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to fill this gap by comparing the effectiveness of intravenous magnesium sulfate versus terbutaline in children with acute asthma exacerbations, providing evidence-based guidance for clinicians in emergency settings.

Detailed description: Despite the established roles of both magnesium sulfate and terbutaline in the management of severe asthma exacerbations, there is limited comparative data on their efficacy and safety in the pediatric population. Understanding the relative benefits and risks of these therapies is crucial for optimizing treatment strategies and improving patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Known cases of asthma
* Minimum duration of asthma as 6 months
* Presenting with acute exacerbation of asthma
* Requiring emergency treatment.

Exclusion Criteria:

* Children having chronic respiratory diseases (cystic fibrosis, bronchopuonary dysplasia)
* Children with cardiac diseases
* Children who were hospitalized in the past 2-weeks due to any reasons
* Children using oral or intravenous corticosteroids or other systemic medications
* Children who were unable to undergo PEFR measurements due to any reasons

Primary outcomes:
measure: Post-treatment PEFR
timeFrame: 4 hours
Secondary outcomes:
measure: Oxygen Saturation
timeFrame: 4 hours
measure: Heart Rate
timeFrame: 4-hours
measure: Respiratory rate
timeFrame: 4 hours
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Nishtar Hospital
state: Punjab
Study officials:
affiliation: Department of Pediatrics, Nishtar Hospital, Multan, Pakistan
name: Arif Zulqarnain, FCPS
role: STUDY_DIRECTOR
affiliation: Department of Pediatrics, Nishtar Hospital, Multan
name: Muhammad Salman, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05901220: Joint School-Health Project of the Neapolitan Child
Official title: Joint School-Health Project of the Neapolitan Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Condition
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 223
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Unhealthy lifestyle habits during the childhood could negatively impact the health status actual and during the later stages of life.

The School represents the major Institution to implement actions aim at promoting healthy lifestyles habits.

The Joint School-Health Project of the Neapolitan Child aimed at assessing the impact of a health education programme to improve lifestyle habits during the childood. To evalute the effects of this educational programme, the dietary habits, the sleep hours, the hours spent in sedentary behaviors (tv, smartphone) and the hours of physical activity will be evaluate at the baseline and at the end of the programme.


Eligibility criteria: Inclusion Criteria:

* students aged 5-13 years of both sex;
* parents/tutor written informed consent.

Exclusion Criteria:

* lack of written informed consent;
* unwillingness to participate.

Primary outcomes:
measure: Intake of energy and nutrients
timeFrame: 7-day
measure: Intake of ultraprocessed foods
timeFrame: 7-day
measure: Intake of dietary advanced glycation end-products
timeFrame: 7-day
measure: Adherence to the Mediterranean Diet
timeFrame: 9 months
measure: The sleep habits
timeFrame: 9 months
measure: The hours spent in sedentary behaviors
timeFrame: 9 months
measure: The hours of physical activity
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References:
Clinical trial NCT05153720: Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients
Official title: Comparison of Ultrasound Guided Erector Spinae Block and Ultrasound Guided Caudal for Perioperative Analgesia in Pediatric Cancer Patients Undergoing Nephrectomy Surgeries: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients


Eligibility criteria: Inclusion Criteria:

* ASA I and II
* Age \>1 and \<12
* patients undergoing nephrectomy surgeries

Exclusion Criteria:

* patients parental refusal
* local infection at the puncture site
* coagulopathy with INR\> 1.6
* unstable cardiovascular disease
* patients allergic to medication used
* development or mental delay
* impaired liver and renal functions

Primary outcomes:
measure: opioid consumption
timeFrame: First 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Yasmen F Abdelghani, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04346420: Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
Official title: Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
Hypoxemia
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.

Detailed description: The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.

Each included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.

Eligibility criteria: Inclusion Criteria:

* COVID-19
* SpO2 between 92 and 96% with low-flow oxygen therapy (\< 15 L/min).

Exclusion Criteria:

* Chronic obstructive pulmonary disease or other chronic respiratory disease
* Confusion
* Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min
* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)

Primary outcomes:
measure: Change in O2 output
timeFrame: At baseline and 30 minutes after wearing both systems
Secondary outcomes:
measure: Comfort with the interfaces
timeFrame: 30 minutes after wearing both systems
measure: Changes in PaO2
timeFrame: At baseline and 30 minutes after wearing DTM
measure: Changes in PaCO2
timeFrame: At baseline and 30 minutes after wearing DTM
measure: Changes in pH
timeFrame: At baseline and 30 minutes after wearing DTM
measure: Changes in respiratory rate
timeFrame: At baseline and 30 minutes after wearing both systems
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels Capital
Study officials:
References:
Clinical trial NCT03172520: Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
Official title: Use of Automatic Periodic Stimulation and Continuous EMG for Facial Nerve Monitoring During Parotidectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parotid Gland Disorders
Keywords: Parotidectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to document the safety of the Medtronic automatic periodic stimulating (APS) Electrode Stimulator during a parotidectomy and potentially prevent post-operative facial nerve weakness, which is a relatively common outcome after parotid surgery.

Detailed description: This study will be conducted in two phases. In the first phase the investigators will use the same monitoring system currently used during parotidectomy and requires placement of the APS electrode as the only additional piece of equipment. During this phase, the investigators will record intraoperative EMG data generated by the monitoring system as well as document intra-operative maneuvers that precede adverse EMG events.

In the second phase of the study the investigators aim to allow the surgeon to alter his or her techniques, with the information provided by the APS electrode, to reverse adverse EMG changes.

Eligibility criteria: Inclusion Criteria:

* Parotidectomy: Planned parotid gland surgery (superficial or total parotidectomy)
* Benign or malignant disease

Exclusion Criteria:

* Current pregnancy
* Preoperative facial nerve dysfunction
* Revision surgery
* History of preoperative radiation to the surgical field
* Retrograde or extracapsular dissection
* Intentional nerve sacrifice (i.e., due to nerve involvement by tumor)
* Tumors with proximity to main trunk of facial nerve
* Inability to place electrode
* Presence of electrode alters surgical technique

Primary outcomes:
measure: Change in Electromyography (EMG)
timeFrame: baseline, approximately 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric J Moore
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457620: Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients
Official title: Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Injuries
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation.

Detailed description: The objective is to assess whether telerehabilitation can provide comparable or significantly better outcomes in terms of functional recovery, pain management, improved range of motion, and patient satisfaction for Total Knee Replacement (TKR) patients. If telehealth interventions prove successful, they can be implemented to increase access to high-quality rehabilitation treatments and enhance healthcare delivery. Evidence-based findings from this study can help healthcare providers make educated decisions about incorporating telerehabilitation into post-operative rehabilitation protocols, thereby enhancing patient care and optimizing resource utilization in orthopedic settings.

Eligibility criteria: Inclusion Criteria:

* Male and female patients diagnosed with TKR
* Older Age above 65
* Patient communicates with medical staff
* Patient with cemented TKA
* Patients who underwent TKA owing to degenerative arthritis

Exclusion Criteria:

* Older patients aged \>75 years
* Patient with a history of knee joint surgery before TKA
* Patient who possibly had a systematic inflammatory disease such as rheumatoid arthritis.
* Patients with difficulty in seeing, hearing, and walking independently
* Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
* Patient history of severe mobility disorder
* Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WoMAC)
timeFrame: 12 Months
measure: Knee Outcome Survey-Activities of Daily Living (KOS-ADLS)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Acti Life Physiotherapy and Rehabilitation Center Horizon Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT05364320: A Study to Evaluate Spine Motion in Older Adults
Official title: Lumbar Spine Range of Motion and EMG Outcomes in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mayo Clinic's elderly adult patients or residents of Rochester MN with minimum age of 50 years.

Brief summary: This study is being done to measure real-world motions and forces in the spine during everyday activities. This information will be used to develop and validate a computer model of how the spine moves and determine injury risk.

Detailed description: Kinematic motion data will be collected at 120 Hz using a 14-camera Real Time Motion Analysis system. Cortex software (Motion Analysis Corp., Rohnert Park, CA) will be used to visualize the data during physical activities. A developed Matlab code will be used for data analysis. Statistical parametric mapping (SPM) will be used to collect the entire kinematic motion waveforms to compare motion profiles of different individuals. Also, the peak values for each activity will be captured for statistical analysis. Muscle response and electrical activity, which will be used to estimate muscle forces, will be recorded during gait analysis from the paraspinal lumbar muscles using an EMG system. Surface electrodes will be attached to the lumbar spine. EMG data will be collected at 2400 Hz. For each participant, the investigators will record five trials per activity.

Additionally, gait speed as well as static and dynamic balance will assess. Knee and grip strength will also be measured. Finally, physical activity levels will be assessed both objectively and subjectively.

Eligibility criteria: Inclusion Criteria:

* Age 50 and over
* Ability to perform trunk flexion, lateral bending, and axial rotation, as well as lift at least 5 pounds of weight from the floor

Exclusion Criteria:

* Spinal pathologies
* Physiological and neuromuscular disorders
* BMI\>35
* Knee or hip replacement in the past 12 months
* Use of assistive devices
* Frailty: with FRAIL score of 3 or greater

Primary outcomes:
measure: Thoracic and lumbar spine ranges of motions in degrees
timeFrame: Day 1
measure: Paraspinal muscle activities in Newtons
timeFrame: Day 1
Secondary outcomes:
measure: Upper extremity strength in Newtons
timeFrame: Day 1
measure: Lower extremity strength in Newton-meters
timeFrame: Day 1
measure: Physical activity levels measured by IPAQ questionnaire in MET-minutes per week
timeFrame: Day 1
measure: Physical activity levels measured by accelerometry in MET-minutes per week
timeFrame: Day 5
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenton Kaufman, PhD
role: PRINCIPAL_INVESTIGATOR
References: