louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06255236: Pediatric Frontal and Nasal Bispectral Index
Official title: An Accuracy of Bispectral Index Monitoring in an Alternative Nasal Position Compared With Standard Frontal Position in Pediatric Patients Under General Anesthesia With Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BIS
Keywords: Pediatric anesthesia
Intraoperative care
Intraoperative neurophysiological monitoring
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2024-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.

Detailed description: Standard position of frontal bispectral index (BIS) may not be available in some operations that frontal area is occupied by surgical field. This prospective cohort study aims to compare the accuracy of the BIS between an alternative position across the nasal area with the standard frontal BIS position in pediatric patients undergoing general anesthesia.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing general anesthesia
* American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* Patients with neurological diseases
* Patients who are using anticonvulsant drugs
* Patients who is expected to be intubated and return to the pediatric intensive care unit
* Patients undergoing head and face surgery
* Patients undergoing surgery in the prone position
* Patients who have contraindications to sevoflurane, thiopental, fentanyl, and cisatracurium

Primary outcomes:
measure: bispectral index (BIS) value
timeFrame: 5 hours
Secondary outcomes:
measure: signal quality index (SQI)
timeFrame: 5 hours
measure: electromyography (EMG)
timeFrame: 5 hours
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Taniga Kiatchai, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson P, Nelson JA, Chen AJ, Kofke WA. An alternative position for the BIS-Vista montage in frontal approach neurosurgical cases. J Neurosurg Anesthesiol. 2013 Apr;25(2):135-42. doi: 10.1097/ANA.0b013e31826ca3a0.
Clinical trial NCT01135836: Reducing Shoulder Tip Pain Following Laparoscopic Surgery
Official title: A Randomized, Controlled, Single Blind Study Comparing a Pulmonary Recruitment Maneuver Versus Intraperitoneal Infusion of Normal Saline to Reduce Shoulder Tip Pain After Gynecologic Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Shoulder Pain
Laparoscopic Surgery
Keywords: Shoulder pain
Gynecologic laparoscopic surgery
Nausea
Vomiting
Abdominal fullness
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2010-06-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery.

The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to reduce carbon dioxide retention in the pelvic cavity.

Detailed description: This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

Eligibility criteria: Inclusion Criteria:

* Patients receive benign gynaecological laparoscopic surgery.
* American Society of Anesthesiologists (ASA) physical status of patient:

classification I-II

Exclusion Criteria:

* The procedure will be required to conversion to laparotomy.
* Any cardio-vascular diseases.

Primary outcomes:
measure: the severity and frequency of shoulder-tip pain after laparoscopic surgery
timeFrame: the first 48 hours after the surgery
Secondary outcomes:
measure: Nausea or abdominal fullness after laparoscopic surgery
timeFrame: the first 48 hours after the surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yi-Jen Chen, Ph.D,
role: STUDY_CHAIR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Hsiao-Wen Tsai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
Clinical trial NCT03140436: Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders
Official title: Clinical Comparison of the Stain Removal Efficacy of Two Air Polishing Powders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stain Removal Efficacy
Keywords: stain removal efficacy, air polishing powder
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a double-blind, randomized split-mouth design.
Primary purpose: TREATMENT

Brief summary: This study was designed to find out the stain removal efficacy and also, to find out the operators and patients opinion when use or receive treatment with both air polishing powders.

Detailed description: Using air polishing with sodium bicarbonate powders with grain size 65 µm provides efficacy in the removal of dental stains but it can cause gingival trauma if used towards the gingiva. Since having big size particles is uncomfortable, the current recommendation according to literature is to use a smaller grain size (40 µm) that results in more patient comfort. However, the efficacy of small grain size on stain removal has not been studied adequately. This study aimed to compare the stain removal efficacy between sodium bicarbonate powders with grain size 65 µm and 40 µm and also to evaluate patient's acceptance after treatment and operator's opinion after using both air polishing powders.

Eligibility criteria: Inclusion Criteria:

1. Healthy subjects who aged over 18 years old.
2. Subjects who have healthy periodontal health or gingivitis.
3. At least 3 upper teeth (anterior, premolar and molar) are presented on both side (right \& left side), which will be refer as index teeth, that did not present with any gingival recession, cervical abrasion and/or abfraction, caries, restoration or orthodontic appliance.
4. Intrinsic stain is not present.
5. Index teeth are presented with extrinsic stain with individual Lobene score scored 2 or above.

Exclusion Criteria:

1. Pregnancy or current breastfeeding mother.
2. Allergy to sodium bicarbonate or the aroma of the powder

Primary outcomes:
measure: The time required for complete removal of extrinsic stains
timeFrame: 2 hr
Secondary outcomes:
measure: Patient acceptance
timeFrame: 2 hr
measure: Operator opinion
timeFrame: 2 hr
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Kanyawat Rattanasuwan
Study officials:
affiliation: Mahidol University
name: Kanyawat Rattanasuwan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00699036: Rosiglitazone Versus Rosiglitazone and Metformin Versus Rosiglitazone and Avandia in the Treatment of Nonalcoholic Steatohepatitis (NASH)
Official title: Rosiglitazone Versus Rosiglitazone and Metformin (Avandamet) Versus Combination Rosiglitazone and Losartan in the Treatment of Nonalcoholic Steatohepatitis (NASH). A Prospective, Open-Label, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver Disease
Keywords: nonalcoholic steatohepatitis (NASH)
fatty liver
insulin resistance
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2008-06-17
Enrollment: 165
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: The purpose of this study is to evaluate the efficacy of rosiglitazone alone compared with rosiglitazone plus metformin or rosiglitazone plus losartan in the treatment of biopsy proven nonalcoholic steatohepatitis (NASH). This study was designed to answer the question: are there differences in the efficacy (as measured by histopathology and insulin resistance) of three different therapeutic modalities used to treat NASH?


Eligibility criteria: Inclusion Criteria:

1. Patients between 18-70 years old
2. Negative urine pregnancy test in females
3. History of elevated liver associated enzymes (ALT \> 40)
4. Liver biopsy within 1 year of screening in this study that shows histopathologic findings consistent with NASH

Exclusion Criteria:

1. ALT greater than three times normal
2. NYHA class 3 or 4 heart failure
3. Any congestive heart failure patient on insulin
4. Patients on one of the 3 study drugs within the past 3 months prior to enrollment
5. Alcohol consumption \>20 gm/day in a female and \> 30 gm/day in a male
6. Evidence of co-existent chronic liver disease to include viral hepatitis, Wilson's disease, autoimmune hepatitis, hemochromatosis, primary biliary cirrhosis, or primary sclerosing cholangitis
7. Serum creatinine on initial screening of greater than 1.4
8. Known hypersensitivity to rosiglitazone, metformin, or losartan
9. Known history of diabetic ketoacidosis
10. Female that is breastfeeding
11. Insulin dependent diabetic

Primary outcomes:
measure: liver biopsy histologic improvement
timeFrame: end of study
Secondary outcomes:
measure: serum transaminases
timeFrame: throughout study (ongoing)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Dawn M Torres, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05415436: Analyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure
Official title: Analyzing the Relationship Between Rate of Induction and Perioperative Hypotension Using Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypotension on Induction
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the hemodynamic changes related to Propofol administration rate. We hypothesize that slow administration of IV propofol will have less hemodynamic disturbances and will require less amount of vasoactive medication for BP correction when compared to standard FDA approved administration rate.


Eligibility criteria: Inclusion Criteria:

* any patient from 18 till 80 years of age
* patient undergoing non-cardiac elective surgery
* duration of the surgery longer than one hour
* native/fluent English speaker
* patients whose staff anesthesiologist planned to use Propofol as a primary anesthetic for induction

Exclusion Criteria:

* any patient admitted for non-elective surgery
* any patient undergoing cardiac surgery
* any patient under 18 years of age
* any patient older than 80 years of age
* any patient with history of severe heart disease (CHF with significant limitations of activity due to sever symptoms, prior heart surgery, atrial fibrillation, etc.)
* any patient with pre-operative hemodynamic instability (e.g. sepsis, chronic kidney disease, liver cirrhosis) who requires constant or intermittent administration of vasoactive or inotropic medication to support vital signs (BP)
* any patient on vasoactive or inotrop medications in early pre-operative period (within 24 hours prior to the surgery)
* any patient who does not speak English or not fluently
* any patient with cognitive impairment or mentally incapacitation
* any pregnant or breastfeeding females
* any patient whose staff anesthesiologist planned to use a primary anesthetic other than Propofol

Primary outcomes:
measure: Patients Administered Propofol at a Slower Rate of Infusion Will Have Lower Incidence of Post Induction Hypotension Than Patients Administered Propofol at FDA Approved Rate.
timeFrame: induction to 1 hour post induction
Secondary outcomes:
measure: Patients Administered Propofol at a Slower Rate Will Have Less Complications During the Early Post-op Period Than Patients Administered Propofol at FDA Approved Rate.
timeFrame: immediate post-op to 30 days post operatively
Other outcomes:
Locations:
city: Toledo
country: United States
facility: The University of Toledo Medical Center
state: Ohio
Study officials:
affiliation: University of Toledo
name: Scott Pappada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161536: Evaluation of the Performance of the Motus Cleansing System
Official title: Evaluation of the Performance of the Motus Cleansing System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Procedure
Lead sponsor: Motus GI Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Bowel cleansing level was evaluated by using the Boston Bowel Preparation Score (BBPS) at baseline and after the use of the Motus Cleansing System.
Primary purpose: SCREENING

Brief summary: The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.

Detailed description: Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4\*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.

following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.

Eligibility criteria: Inclusion Criteria:

* Subjects in the age range of 18-75 years
* Subjects with BMI within the range of 18.5-35
* Subject is willing to sign informed consent form

Exclusion Criteria:

* Active or severe IBD
* Subjects with severe diverticulitis \\ diverticular disease (known or detected)
* Known or detected colonic stenosis
* Known or detected bowel obstruction
* History of prior colon surgery
* ASA≥IV (sever systemic disease)
* Sever Renal insufficiency
* Sever Liver insufficiency
* Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent pregnancy
* Subjects with altered mental status/inability to provide informed consent
* Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly

Primary outcomes:
measure: The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem
timeFrame: Following the colonoscopic procedure- Up to 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Motus GI Technologies Ltd.
name: Ravit Peled
role: STUDY_DIRECTOR
References:
Clinical trial NCT01902836: Efficacy Study of Dialyzed Leukocytes Extracts to Treat Paediatric Moderate Atopic Dermatitis
Official title: Efficacy of Human Dialyzed Leukocytes Extracts in Paediatrics Patients With Moderate Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Childhood Atopic Dermatitis
Keywords: Dialyzable Leukocyte Extracts
Transferon
atopic dermatitis
Lead sponsor: National Polytechnic Institute, Mexico
Sponsor class: OTHER
Collaborators: name: Hospital Infantil de Mexico Federico Gomez
name: Instituto de Oftalmología Fundación Conde de Valenciana
First posted: 2013-07-18
Enrollment: 58
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.


Eligibility criteria: Inclusion Criteria:

* Atopic dermatitis diagnosis by Hanifin and Rajka classification
* Dermatitis severity: Moderate, according with SCORAD index.
* Patients without treatment of topical steroids or immunosuppressants in the last 3 weeks.
* Patients with "informed consent form" signed by both parents, or advisor.
* Patients 7 years old or older whom have signed the assent form

Exclusion Criteria:

* Patient who were treated with topical, or systemic steroids and/or immunosuppressants and they cannot discontinue their treatment.
* Patients who lived far from the hospital and they could not go to the visits.

Primary outcomes:
measure: Clinical outcome evaluated by SCORAD
timeFrame: Day 14
Secondary outcomes:
measure: Immunophenotypical changes induced by adjuvant treatment (DLE) (oral Transferon)
timeFrame: 28 days
Other outcomes:
Locations:
city: México
country: Mexico
facility: Hospital Infantil de México, Fedérico Gómez
state: DF
Study officials:
affiliation: Hospital Infantil de Mexico Federico Gomez
name: Mirna Toledo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01460836: Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
Official title: Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-27
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis

Brief summary: Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.


Eligibility criteria: Inclusion Criteria:

* ≥ 6 years of age with a documented Cystic fibrosis (CF) diagnosis,
* moderate-to severe lung disease,
* the ability to perform reproducible pulmonary function tests,
* Pseudomonas aeruginosa (PA) airway infection.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
timeFrame: Baseline, Weeks 2, 4 and 6
Secondary outcomes:
measure: Mean change in the density of Pseudomonas aeruginosa (PA) from baseline
timeFrame: Baseline, Weeks 2, 4 and 6
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02058836: Botulinum Toxin for the Management of Chronic Orchialgia
Official title: Botulinum Toxin for the Management of Chronic Orchialgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Testicular Pain
Keywords: Chronic testicular pain
Orchialgia
Botulinum toxin
Botox
Urology
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2014-02-10
Enrollment: 8
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if Botox injections will provide relief from chronic testicular pain. In the study, the spermatic cord of particpants will be injected with either Botox or a placebo of saline. Botox is currently used to treat other urological conditions like overactive bladder and lower urinary tract problems. For these conditions, Botox works by relaxing muscles in the affected areas. The investigators believe that Botox will act similarly in the treatment chronic testicular pain.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic testicular pain (orchialgia)

Exclusion Criteria:

* Active infection of urinary tract (UTI)
* Active infection of the scrotal skin of the affected side
* Bilateral orchiectomy

Primary outcomes:
measure: Visual Analog Scale for Pain Score
timeFrame: Baseline and 1 Week Post Injection
measure: Visual Analog Scale for Pain Score
timeFrame: 1 month
measure: Visual Analog Scale for Pain Score
timeFrame: 3 months
measure: Visual Analog Scale for Pain Score
timeFrame: 6 months
measure: Quality of Life Questionnaire Score
timeFrame: 1 week
measure: Quality of Life Questionnaire Score
timeFrame: 1 month
measure: Quality of Life Questionnaire Score
timeFrame: 3 months
measure: Quality of Life Questionnaire Score
timeFrame: 6 months
measure: Units of Analgesics Used for Testicular Pain
timeFrame: 1 week
measure: Units of Analgesics Used for Testicular Pain
timeFrame: 1 month
measure: Units of Analgesics Used for Testicular Pain
timeFrame: 3 months
measure: Units of Analgesics Used for Testicular Pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ryan P Terlecki, MD
role: PRINCIPAL_INVESTIGATOR
References: