louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03339375: The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy in Severe Trauma Patients
Official title: The Effect of Esophageal Doppler Guided Goal-directed Hemodynamic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe trauma patients

: Injury severity score \> 15

Brief summary: Prospective randomized clinical trial Compare the goal-directed fluid therapy using esophageal Doppler and classic fluid therapy

Detailed description: Goal directed fluid therapy becomes issue for enhanced recovery after surgery. In goal directed therapy, dynamic parameters, like stroke volume and cardiac output, is important. Esophageal Doppler is one of device which provides dymanic parameters.

In severe trauma cases, the effect of goal directed therapy is not known yet. So the aim of this study is comparing the results of goal directed therapy using esophageal Doppler and conventional fluid therapy.

Eligibility criteria: Inclusion Criteria:

* Severe trauma patients who undergo general anesthesia
* Initial serum lactate level \> 2mmol/L

Exclusion Criteria:

* Severe traumatic brain injury
* THoracic surgery
* Age \< 19 years old
* Impending arrest or post CPR state
* Severe facial trauma

Primary outcomes:
measure: Lactate
timeFrame: Immediate postoperative (=initial ICU admission)
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II (APACHE II) score
timeFrame: Immediate postoperative
measure: Creatinine
timeFrame: Immediate postop
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 NCT05821075: Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
Official title: Comparative Study Between Prednisolone, Cerebrolysin in the Treatment of Bell's Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Bell Palsy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies.

Many patients with Bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating Commonly used medications to treat Bell's palsy is Corticosteroids Cerebrolysin stimulates the regeneration of the nervous tissue with protective action we aim to study the efficacy of cerebrolycin in Bell's palsy


Eligibility criteria: Inclusion Criteria:

* unilateral acute facial palsy of no identifiable cause

Exclusion Criteria:

* Recurrent facial Bell's palsy
* Pregnancy
* Diabetes
* Epilepsy
* Severe hypertension,
* Renal or hepatic disease,
* Gastric or duodenal ulcer
* presence of acute otitis media or ipsilateral chronic otitis
* Recent head injury,
* psychiatric disease
* If there is any contraindications for corticosteroids

Primary outcomes:
measure: change in scores of the house Brackman grading system HB
timeFrame: at baseline, after 1 week, after 3 week
measure: changes in scores of the Sunnybrook grading system.
timeFrame: at baseline, after 1 week, after 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 university hospital
Study officials:
References:
Clinical trial NCT02888275: Dexmedetomidine in Pediatric Cardiac Surgery
Official title: The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 144
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.

Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.

The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing congenital cardiac surgery

Exclusion Criteria:

* history of allergy or anaphylaxis to study drug
* preexisting renal dysfunction (preoperative creatinine \>1.5mg/dl)
* diabetes
* liver profile abnormality

Primary outcomes:
measure: serum creatinine
timeFrame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Secondary outcomes:
measure: glomerular filtration rate
timeFrame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
measure: Urine output
timeFrame: immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT03904875: Air Pollution and COPD Exacerbation
Official title: Impact of Air Pollution on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Haut de France. BePoPi Project.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pollution; Exposure
Chronic Obstructive Pulmonary Disease
Keywords: pollution
Chronic Obstructive Pulmonary Disease
ultrathin particles
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Clinique de l'Europe, Amiens
name: University Hospital, Lille
First posted: 2019-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie and Lille, and Clinique de l'Europe between 01/01/2020 and 31/12/2020 will be included. Home and work address and spirometric data will be collected. Atmo Hauts-de-France will collect daily data on PM10, PM2,5, NO2 et O3 in Amiens and Lille metropoles. Odours and pollens will be collected too by ATMO Haut de France.

Brief summary: There is an excess of hospitalization rates for acute exacerbation of COPD in Picardy compared to the national data. A first study realized in Picardy has shown a link between air quality and COPD. Nevertheless, the particles type is unknown and according to it, impact on COPD could be different. The investigator goal is to find a correlation between acute exacerbation of COPD consultation rate and daily ultra thin particles in Haut de France. The investigators will correlate the particles composition with daily acute exacerbation of COPD rate. All COPD patients with a diagnosis of acute exacerbation in emergency room in University Hospital of Amiens-Picardie and Lille, and Clinique de l'Europe between 01/01/2020 and 31/12/2020 will be included. For each patient, home and work address will be collected. The duration of 1 year was chosen to take into account seasonal variations. In parallel, a daily report of the rate of ozone, particles (PM2.5 and PM10), dioxide nitrogen but also odours and pollens will be done by ATMO Haut de France.


Eligibility criteria: Inclusion Criteria:

* COPD patients with a diagnosis of acute exacerbation of COPD in the emergency room of Amiens and Lille centers
* Adults
* Patients able to express consent
* signed written informed consent form
* covered by national health insurance

Exclusion Criteria:

* patients non covered by national health insurance
* patients not able to express consent
* minors

Primary outcomes:
measure: daily rate of COPD exacerbation consultation in the emergency room of the 3 centers
timeFrame: every day during 12 months
measure: ultrathin particles quantity in the air
timeFrame: every day during 12 months
Secondary outcomes:
measure: chemical composition ultrathin particles
timeFrame: every day during 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01343875: Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biceps Tendon Rupture
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-04-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men and women that went to surgery due to tear of the distal tendon in the biceps muscle.

Brief summary: Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure.

Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.


Eligibility criteria: Inclusion Criteria:

1.see population description

Exclusion Criteria:

1. Unwillingness to come to the clinic visit.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06285175: REINVENT: A Brain and Muscle Computer Interface for Stroke
Official title: REINVENT: A Brain and Muscle Computer Interface for People With Severe Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 14
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: TREATMENT

Brief summary: Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (\>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe upper extremity hemiparesis and residual hand function (e.g., less than 20 degrees of active wrist or finger extension and enough muscle activity to measure with electromyography).

Exclusion Criteria:

* Taking anti-spasticity medication
* Significant vision loss (corrected vision is acceptable)
* Receptive aphasia
* Hand contractures
* Secondary neurological disease

Primary outcomes:
measure: Fugl Meyer Assessment - Upper Extremity
timeFrame: Through study completion, an average of 1 month
measure: Maximum EMG activity
timeFrame: Through study completion, an average of 1 month
measure: Corticomuscular coherence
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT06146959: Corrective Calcaneal Kinesiology Tape in Adolescents With Pronated Foot
Official title: Effect of Corrective Calcaneal Kinesiology Tape on Pain, Function and Sonographic Picture of Plantar Fasciitis in Adolescents With Pronated Foot
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Physical Disability
Physical Therapy Modalities
Keywords: Kinesiology tape , plantar fasciitis
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2023-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of plantar fascia in adolescents with pronated feet.This study hypothesizes that there will be a statistically significant effect of a program of application of the corrective technique of kinesiotaping on plantar heel pain, foot function, and the sonographic picture of plantar fascia in a sample of Egyptian adolescents suffering from pronated feet.

Detailed description: This study will be conducted to find the effect of a program of corrective kinesiotaping on pain intensity, foot function, and the sonographic picture of the plantar fascia in adolescents with pronated feet. Thirty adolescents suffering from plantar heel pain associated with pronated feet will be included in this study. They will be distributed randomly into 2 groups: Group A will receive corrective kinesiotaping (50-75% stretch) for 6 weeks, 2 times per week with 1 day of rest; Group B will receive a home program of intrinsic foot strengthening and stretching exercises. Data will be collected pre- and post-intervention for all groups by using the visual analog scale (VAS), the first two subscales of the foot function index (FFI), and a sonographic picture of the foot for each adolescent. Participants will be recruited from outpatient clinics and schools.

Eligibility criteria: Inclusion Criteria:

* Children with unilateral or bilateral plantar fasciitis.
* pronated foot or foot on weightbearing in the navicular drops test.
* Pain and tenderness to palpation at the medial tubercle of the calcaneus for a minimum of 6 weeks and maximum of 6 months

Exclusion Criteria:

* Corticosteroid injection of the heel within the past 3 months.
* Posterior heel pain.
* Systemic inflammatory conditions.
* Diabetes.
* Surgery of the foot.
* Neuromuscular conditions e.g. CP.
* Individuals with BMI \> 25.
* Individuals engaged in regular athletic activities

Primary outcomes:
measure: Pain Visual Analogue Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Foot function Index
timeFrame: 4 weeks
Other outcomes:
measure: Diagnostic ultrasound
timeFrame: 4 weeks
Locations:
city: Cairo
country: Egypt
facility: Tayseer Younes
state: Al Qahirah
Study officials:
affiliation: Beni-Suef University
name: Tayseer S Abdeldayem, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04817059: Reducing Head Motion With Customized Head Mold in Young Children
Official title: The Impact of Customized Head Molds on Motion and Motion-related Artifacts From Structural and Functional MRI Scans in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Adhd
Neuroimag
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 21
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of a customized head mold for reducing head motion during MRI scanning in young children.

Detailed description: Each participant completed a dedicated session for mock scanning before we acquired two sets of sMRI and fMRI scans. One scan set was collected using the head mold and the other without, and the scans were counterbalanced in order across participants. Using a specialized sMRI sequence embedded with vNAVs, we directly measured head motion during sMRI in order to more accurately evaluate the head mold's impact on structural metrics. To evaluate the feasibility and tolerability of the head mold, we concluded the scanning sessions with a brief interview that gauged participants' scanning experience and tolerance of the head mold. We investigated whether head molds would reduce head motion compared to standard scanning procedures and whether those reductions would result in improved data quality. We also tested the extent to which reductions in head motion impacted estimations of cortical volume and functional connectivity. Prior to data collection, we evaluated the noise dosage levels of the head mold condition, given the limited space available for additional hearing protection devices in the head coil while the head mold is on. We also assessed whether the head molds could balance head motion between typical and ADHD populations, and whether clinical variables such as ADHD diagnosis and trait anxiety, as determined by parent-reported dimensional measures, can predict head mold efficacy.

Eligibility criteria: Inclusion Criteria:

* between ages 5 - 10
* ADHD diagnosis as determined by parent self-report

Exclusion Criteria:

* no MRI contraindications and no history of head injuries or seizures.

Primary outcomes:
measure: Head motion during MRI scanning
timeFrame: during MRI scanning
Secondary outcomes:
measure: Image quality
timeFrame: during MRI scanning
Other outcomes:
Locations:
city: Austin
country: United States
facility: Health Discovery Building Biomedical Imaging Center
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Cameron Craddock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213159: Dexmedetomidine for Postoperative Analgesia After Bariatric Surgery
Official title: Intraoperative Dexmedetomidine Versus Morphine for Postoperative Analgesia After Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Sleep Apnea
Diabetes
Hypertension
Keywords: Dexmedetomidine
bariatric surgery
postoperative pain
morphine consumption
Quality of recovery
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 60
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 purpose of this study is to determine if Dexmedetomidine given at the end of surgery will reduce postoperative morphine consumption and improve postoperative quality of recovery as compared to morphine in patients undergoing laparoscopic bariatric surgery.

Detailed description: effect of Dexmedetomidine bolus on postoperative morphine requirements

Eligibility criteria: Inclusion Criteria:

* Body Mass Index \> 40 kg/m2 or BMI \> 35 kg/m2 with comorbid conditions such as hypertension, diabetes or sleep apnea
* American Society of Anesthesiologists class I or II
* Undergoing laparoscopic sleeve gastrectomy bariatric surgery

Exclusion Criteria:

* Allergy to morphine or its derivatives
* Allergy to α-2 adrenergic agonists
* weight over 180 kg
* history of uncontrolled hypertension
* heart block greater than first degree
* prolonged QT interval
* clinically significant neurologic, cardiovascular, renal, hepatic, or gastrointestinal diseases
* received an opioid analgesic medication within a 24 h period prior to surgery
* history of alcohol, drug abuse or chronic opioid intake
* history of psychiatric disorder
* pregnant or breastfeeding.

Primary outcomes:
measure: Total dose of morphine consumed in Post Anesthesia Care Unit (PACU)
timeFrame: At discharge from the PACU
Secondary outcomes:
measure: Time to first morphine requirement in PACU
timeFrame: in the PACU
measure: Numeric Rating Scale (NRS) for Pain
timeFrame: in the PACU and at 24 hours
measure: NRS for nausea
timeFrame: in the PACU
measure: incidence of pruritus
timeFrame: in the PACU
measure: incidence of vomiting or retching
timeFrame: in the PACU
measure: incidence of respiratory complications
timeFrame: in the PACU
measure: time to discharge readiness in PACU
timeFrame: in the PACU
measure: total morphine consumption at 24 hours
timeFrame: at 24 hours
measure: Quality of Recovery (QoR-40) score at 24 hours
timeFrame: at 24 hours
measure: overall satisfaction at one month
timeFrame: one month after surgery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: AUBMC
name: Carine Zeeni, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AUBMC
name: Sahar Siddik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: