louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04821947: Rhomboid Intercostal Plane Block vs Local Anesthetic Infilteration for Postoperative Analgesia After Thoracoscopic Surgery
Official title: Effects of Rhomboid Intercostal Plane Block for Postoperative Analgesia After Thoracoscopic Surgery Compared With Local Anesthetic Infilteration: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluatethe effects of rhomboid intercostal block( RIB ) on postoperative pain after thoracoscopic surgery compared with local anesthetic infiltration ( LA )


Eligibility criteria: Inclusion Criteria:

* ASA status I \&II

Exclusion Criteria:

* Allergic constitution
* Severe cardiovascular or hepatorenal insufficiency
* Coagulation system disease
* Injection site infection
* Morbid obesity (BMI\>40 kg/m2).

Primary outcomes:
measure: Total amount of postoperative analgesic consumption
timeFrame: First 24 hours postoperative
measure: Visual Analogue Score ( VAS )
timeFrame: First 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02068898: Pharmacokinetic Comparison of XS003 and Tasigna
Official title: A Comparative, Proof of Concept Study, Comprising of a Pilot Phase Bioavailability Study Part and a Randomised, Cross-over Food-effect Study Part of "XS003" and Originator in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: XSpray Microparticles
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.

Detailed description: The study consists of two parts, the first part is composed as a pilot part and compares the bioavailability of single oral doses of XS003 compared to Tasigna® given as single oral dose in healthy male subjects. The second part is a food-effect part which assesses the food effect of a single oral dose of XS003 in healthy male subjects either fed or fasted. The study will also evaluate safety and tolerability of XS003 as secondary objectives.

Eligibility criteria: Inclusion Criteria:

* Healthy males
* Age 18 to 55 years of age
* Body mass index (BMI) of 18.0 to 29.0 kg/m2
* Laboratory parameters in normal range

Exclusion Criteria:

* Females
* Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening.
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
* History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator.
* Subject has a QTcF\>450 ms based on ECG at screening or a history of additional risk factors for Torsades de Pointe (e.g. hypokalaemia, hypomagnesemia, a family history of long QT syndrome)

Primary outcomes:
measure: Bioavailability of Nilotinib
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
Study officials:
affiliation: XSpray Microparticles
name: XSpray Microparticles
role: STUDY_DIRECTOR
References:
Clinical trial NCT01154998: Case-Control Study of Fibrotic Interstitial Lung Disease (ILD) and Cardiac Disease / Interventions.
Official title: Case-Control Study of Fibrotic Interstitial Lung Disease and it's Association With Cardiac Disease or Cardiac Intervention.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Idiopathic Pulmonary Fibrosis
Interstitial Pneumonia
Keywords: non-specific interstitial pneumonia
Lead sponsor: St George's Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases - patients with IPF or UIP. Controls - hospital clinic attenders.

Brief summary: There is a rare condition causing scarring of the lungs termed interstitial lung disease. This comprises a group of conditions which can be divided into separate diseases. The aim of this study is compare a group of patients (the cases) with 2 types of this disease (fibrotic non-specific interstitial pneumonia (NSIP) and idiopathic pulmonary fibrosis (IPF)) with patients without the disease. The study will look at the 2 groups and their exposures to factors such as medications, smoking, previous jobs, previous medical problems and specifically heart disease and any operations or procedures involving the heart. There have been previous studies showing a link between heart disease and scarring of the lungs. This study will look at whether this association is stronger in one or the other type of lung scarring diseases.


Eligibility criteria: Inclusion Criteria:

* idiopathic fibrotic lung disease

Exclusion Criteria:

* non idiopathic fibrotic lung disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Hospital
Study officials:
References:
Clinical trial NCT00853398: MINIMALLY INVASIVE SURGERY in Total Knee Arthroplasty
Official title: A Prospective (Non)-Randomized Controlled Multicenter Clinical Study Of the Genesis ii Total Knee System in Minimally Invasive Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: Primary Osteoarthritis of the knee.
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Overall study design:

A prospective, randomized, multi-center clinical studies comparing the minimal invasive and the standard surgical total knee replacement technique (control) using the Genesis II total knee system. The study will collect efficacy, safety and socio-economical data over 2 years. An additional 5 years follow-up interval is optional. The objectives (short-term follow-up) of the study are to:

1. Assess whether the improvement in Pain and Range of motion per Knee Society scoring system and VAS score.
2. Assess whether there are any differences between the surgical techniques as regards complication rate.
3. Assess whether the hospital stay and the rehabilitation time (Straight leg raise, Active/passive ROM) of the patients differs between the two techniques.
4. Assess the x-ray mechanical alignment between the two techniques.

Attempts will be made to assess whether the collected peri-operative data (including incision length, blood loss, wound appearance, hospital readmissions and operative time) differs between the two surgical techniques.

The primary objectives (mid-term follow-up) of the study are to:

1. Improvement in Pain and Function per Knee Society Scoring system
2. Number and Extent of Radiographic Lucencies \>2mm
3. Revision and knee-related adverse events
4. Improvement in Quality-of-life via the VAS score

5 investigational sites will participate and enroll a total of approximately 250 patients over a 12 months period. Thus, each site will enroll 50 patients.


Eligibility criteria: Inclusion Criteria:

* require primary uni- or bilateral total knee arthroplasty; available for 2 year follow up; provide informed consent; is in stable health for cardio-pulmonary conditions.

Exclusion Criteria:

* inefficient femoral or tibial bone stock; BMI \>35; fixed flexion deformity \>15 degrees; knee flexion of \<90 degrees; varus/valgus deformity \>20 degrees; active local infection; conditions that would compromise the 2 years follow up.

Primary outcomes:
measure: Pain and Range of Motion on the short term as efficacy measurements. Occurence of Adverse Events as safety measurements
timeFrame: 1 year
Secondary outcomes:
measure: Occurence of Adverse Events and Radiolucent lines > 2mm Range of motion on the mid term
timeFrame: 2 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Orthopaedic Department, University Hospital
Study officials:
References:
Clinical trial NCT03760198: Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis Primary Focal Axilla
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is intented to evaluate the efficacy and safety of MEDITOXIN compared to placebo in treatment of primary axillary hyperhidrosis.


Eligibility criteria: Inclusion Criteria:

* adult patients aged from 20 to 65, with persistent bilateral primary axillary hyperhidrosis

Exclusion Criteria:

* those who have secondary hyperhidrosis
* those who have systemic neuromuscular junction disorders
* women who are pregnant or lactating

Primary outcomes:
measure: the proportion of treatment responder
timeFrame: 4 weeks after the injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic University St. Paul Hospital
state: Dongdaemun-gu
Study officials:
References:
Clinical trial NCT06356298: Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy
Official title: Airway Management Effects of Flexible Reinforced Laryngeal Mask Airway Versus Endotracheal Tube for Childhood Adenotonsillectomy：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia Intubation Complication
Airway
Adenotonsillectomy
Children
Lead sponsor: Maternal and Child Health Hospital of Hubei Province
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare the airway management effects of flexible reinforced laryngeal mask and endotracheal tube in childhood adenotonsillectomy.

Participants will be randomly allocated to two groups: endotracheal tube group (ETT) and flexible reinforced laryngeal mask group (FLMA). For those in ETT group: they will be intubated after induction of anesthesia .For those in FLMA group: they will be put in flexible reinforced laryngeal mask after induction of anesthesia .

The investigators will compare FLMA with ETT to see if flexible reinforced laryngeal mask can be used safely and effectively in childhood adenotonsillectomy，and if there will be less severe adverse events in FLMA.


Eligibility criteria: Inclusion Criteria:

* patients who choose to have adenotonsillectomy surgery
* the American Society of Anesthesiologists (ASA) physical status ranked I-II
* the oropharyngeal anatomy is normal
* competent to provide informed consent

Exclusion Criteria:

* upper respiratory tract infection one week before surgery
* oropharyngeal anatomy is abnormal
* high risk of reflux aspiration
* liver or kidney failure
* psychiatric disorders

Primary outcomes:
measure: Peak airway pressure
timeFrame: intraoperative period,10 minutes-1 hours
measure: Petco2
timeFrame: intraoperative period,10 minutes-1 hour
measure: Ventilation leakage or not
timeFrame: intraoperative period,10 minutes-1 hour
Secondary outcomes:
measure: Mean arterial pressure (MAP)
timeFrame: Intraoperative period, 30 minutes - 1.5 hours
measure: Heart rate (HR)
timeFrame: Intraoperative period, 30 min - 1.5 hours
measure: Recovery time
timeFrame: Postoperative 30 minutes
measure: Extubation time
timeFrame: Postoperative 30 minutes
measure: Dosage of anesthetic
timeFrame: Intraoperative period, 30 minutes - 1.5 hours
measure: Success of FLMA or ETT
timeFrame: Intraoperative period, 10 minutes - 1hour
measure: Surgeon satisfaction
timeFrame: Postoperative 30 minutes
measure: Adverse events
timeFrame: Postoperative 1 hour
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
Study officials:
affiliation: Maternal and Child Health Hospital of Hubei Province
name: Na Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02836145: Biomolecular Messages Associated With the Differentiation of Human Induced Pluripotent Stem Cells to Skeletal Muscle Progenitor Cells
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Female Urinary Incontinence and Pelvic Organ Prolapse
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-07-18
Enrollment: 6
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cell lines (human induced pluripotent stem cells, hiPSCs)

Brief summary: Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged women that frequently cause urogenital infection, voiding difficulty, urinary retention, pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal status. Despite playing a crucial role in the pathophysiology of the above diseases, the urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment modalities.

The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for current research and future cell therapy because of their significant self-renewal, differentiation potential and the relative lack of ethical conflict. With the advent of efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs, researchers can generate personalized lines of cells from which it will be possible to obtain differentiated cells in a less invasive way, introducing opportunities in treating diseases that are now considered incurable.

Until very recently, little success has been achieved in terms of skeletal muscle differentiation from hiPSCs. The purpose of this study is to explore the applicability of the differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the associated biomolecular messages. It is anticipated that the derived skeletal muscle progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital problems.


Eligibility criteria: Inclusion Criteria:

* human induced pluripotent stem cells, hiPSCs

Exclusion Criteria:

-

Primary outcomes:
measure: Cell count
timeFrame: Day 50
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01776645: Compassion Training and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether compassion training will improve the physical and psychological well-being of patients with chronic pain. The investigators also want to determine whether any benefit of compassion training in the patients "spreads" to significant others with whom the patient has a close relationship.


Eligibility criteria: Inclusion Criteria:

1. Age 18+ and chronic pain for \>6months
2. Pain over the last month
3. Ability to read, write, and converse in English
4. If being treated for pain condition, then stable treatment regimen.

For significant others:

1)18 years of age or older 2)Ability to read, write, and converse in English

Exclusion Criteria:

For patients and significant others:

1)Current or history of a psychological disorder that would interfere with study procedures, at the discretion of the researcher.

For patients only:

1. prior compassion meditation experience
2. on going legal action or disability claim
3. currently pregnant or planning to become pregnant

Primary outcomes:
measure: Change in Brief Pain Inventory
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Chronic Pain Acceptance Questionnaire
timeFrame: Baseline and end of 9-week treatment protocol
Secondary outcomes:
measure: Change in Brief Pain Inventory
timeFrame: Baseline to end of 9-week treatment protocol
Other outcomes:
measure: Change in Emotional Distress
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Overall Health and Well-being
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Compassion
timeFrame: Baseline and end of 9-week treatment protocol
measure: Qualitative Measures
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Emotional Distress
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Emotional Distress
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Overall Health and Well-being
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Compassion
timeFrame: Baseline and end of 9-week treatment protocol
measure: Change in Compassion
timeFrame: Baseline and end of 9-week treatment protocol
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT01742845: Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid Endarterectomy (CERVECHO)
Official title: Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Atherosclerosis
Regional Anaesthesia Morbidity
Keywords: Ultrasound-guided
regional anaesthesia
Cervical block
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this prospective, randomised, controlled study is to compare the efficacy of ultrasound-guided intermediate cervical block to superficial block for carotid endarterectomy.

Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75 mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed: superficial cervical block (Control group) or, ultrasound guided intermediate cervical block (Echo group). Main outcome is cervical block success, defined by surgery performed under regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of conversion to general anaesthesia, total dose of supplemental topical lidocaine and block-related complications.


Eligibility criteria: Inclusion Criteria:

* patient scheduled for elective carotid artery endarterectomy under regional anaesthesia

Exclusion Criteria:

* indication for general anaesthesia
* known bleedind diathesis
* past medical allergy to local anaesthesic
* severe chronic pulmonary disease
* contralateral diaphragmatic motion abnormalities
* previous cervical ipsilateral surgery
* age \< 18 years

Primary outcomes:
measure: cervical block success
timeFrame: surgery time
Secondary outcomes:
measure: percentage of conversion to general anaesthesia
timeFrame: surgery time
Other outcomes:
measure: percentage of patient needing intraoperative systemic analgesia or sedation
timeFrame: anaesthesia time
measure: amount of local anaesthesic used to performed the block
timeFrame: surgery time
measure: regional anaesthesia-related complications
timeFrame: 7 postoperative days
measure: surgery related complications
timeFrame: 7 postoperative days
Locations:
city: Besançon
country: France
facility: Centre Hospitalier universitaire de Besançon
Study officials:
affiliation: CHRU Besançon
name: Pascal Petit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Sebastien Pili-Floury, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04511598: Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study
Official title: Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 3 Dimensional Soft Tissue Facial Analysis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Precision of 3 Dimensional Facial Analysis Using "Bellus 3D Face Camera Pro" Versus "Planmeca ProMax 3D Proface" is to be evaluated in comparison to direct anthropometry.

Detailed description: The aim of this study will be the evaluation of the precision and reproducibility of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely "Bellus 3D Face Camera Pro" and "Planmeca ProMax 3D ProFace system" and to compare them to physical linear measurements "Direct Anthropometry".

Eligibility criteria: Inclusion Criteria:

1. Age range from 18-35 years.
2. Normal balanced facial proportions.

Exclusion Criteria:

1. Craniofacial anomalies.
2. Obvious skeletal shifts.
3. Patients with incompetent lips.

Primary outcomes:
measure: Precision
timeFrame: 1 Month
Secondary outcomes:
measure: Reproducibility
timeFrame: 1 Month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
state: Giza
Study officials:
References: