louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04829799: Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
Official title: Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain Reduction
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Omeros Corporation
First posted: 2021-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Individuals with a cataract in the surgical eye

Exclusion Criteria:

* Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
* Those with a past medical history of asthma
* Those systemically using opioids or nonsteroidal anti-inflammatory drugs
* Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
* Those with a history of alpha-1-adrenergic antagonist use
* Those with excisional, intraocular surgery in the planned surgical eye in the preceding year
* Those with a history of iris damage
* Those requiring iris expanding device or those with an acute or chronic uncontrolled eye condition, or those unable to effectively remember surgery or complete the post-operative assessment.
* Additionally, individuals less than 21 will be excluded.

Primary outcomes:
measure: Visual analog scale to measure pain
timeFrame: Day 1 of operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Eric Grieser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06935799: Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery
Official title: Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pectus Excavatum
Funnel Chest
Keywords: cryoanalgesia
pain management
pectus excavatum
funnel chest
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 40
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: Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications.

This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Pectus excavatum repair with MIRPE
* Written consent for corrective surgery with intraoperative cryoanalgesia
* Written consent to participate in the study
* Age \>12 and \< 18 years

Exclusion Criteria:

* History of previous thoracic surgeries
* Reoperation for chest deformity
* Contraindication for cryoanalgesia
* Presence of other conditions that may affect the course of the procedures and the assessment of their effectiveness and safety

Primary outcomes:
measure: Postoperative pain level according to Numerical Rating Scale (NRS)
timeFrame: 1 week
Secondary outcomes:
measure: Opioid consumption
timeFrame: 1 week
measure: Duration of the surgery
timeFrame: 1 day
measure: Length of postoperative hospital stay
timeFrame: 1 week
measure: Occurence of early complications
timeFrame: 30 days from the surgery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Children's Memorial Health Institute
state: Wybierz województwo
Study officials:
References:
Clinical trial NCT06002399: Bilateral Monofocal Versus Monofocal-EDOF IOL Implantation: Quality of Vision Comparison
Official title: Combining a Monofocal With an EDOF IOL: Is There an Improvement in Quality of Vision After Cataract Surgery Over Bilateral Monofocal IOL Implantation.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare visual quality after cataract surgery between two groups: bilateral monofocal intraocular lenses (IOL) and monofocal and contralateral extended depth-of-focus (EDOF) IOL implantation. The main question it aims to answer is:

• does the combination of both monofocal and EDOF IOLs presents an advantage over bilateral monofocal IOL implantation in the daily life of patients undergoing cataract surgery without the disadvantages of bilateral EDOF IOL implantation?

Participants will:

* be randomised in either bilateral monofocal group or monofocal and EDOF group
* undergo visual acuity testing with and without correction at all distances
* be asked to complete a quality of vision questionnaire
* undergo non-invasive examinations to measure residual astigmatism, contrast sensitivity, straylight, optical aberrations, reading spead.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 50 and 90 years with bilateral cataract without concomitant exclusion criteria

Exclusion Criteria:

* prior refractive surgery
* patients with corneal opacities, retinopathy, opticopathy, glaucoma, uveitis and amblyopia
* patients with corneal astigmatism greater than 3 diopters (D)
* patients with expected postoperative astigmatism higher than 0.50D
* prior ocular surgery in the last six months
* patients with prior unilateral cataract surgery

Primary outcomes:
measure: Difference in binocular photopic distance corrected intermediate visual acuity between both groups using Radner chart.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00455299: LVHR Multicenter Study
Official title: Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventral and Ventral Insicional Hernia
Keywords: Laparoscopy, ventral, hernia, repair, surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Tyco Healthcare Group
First posted: 2007-04-03
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.

Detailed description: Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation.

Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination.

300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.

Eligibility criteria: Inclusion Criteria:

* secondary or primary ventral hernia

Exclusion Criteria:

* Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3

Primary outcomes:
measure: Operating time
timeFrame: 30-180 min
measure: Adhesion score
measure: Mode of entering abdominal cavity
measure: Pain durance
timeFrame: 8 weeks
measure: Seroma formation
measure: Aesthetic result (protrusion)
timeFrame: 3 years
measure: Infection
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gjøvik
country: Norway
facility: SIHF Gjøvik
city: Oslo
country: Norway
facility: Ullevål University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Jan Lambrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambrecht JR, Vaktskjold A, Trondsen E, Oyen OM, Reiertsen O. Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure. Hernia. 2015 Jun;19(3):479-86. doi: 10.1007/s10029-015-1345-x. Epub 2015 Feb 7.
citation: Lambrecht JR, Skauby M, Trondsen E, Vaktskjold A, Oyen OM. Laparoscopic repair of incisional hernia in solid organ-transplanted patients: the method of choice? Transpl Int. 2014 Jul;27(7):712-20. doi: 10.1111/tri.12327. Epub 2014 May 9.
Clinical trial NCT02448199: Study of Association of Anti-inflammatory and Anti-rheumatic
Official title: Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: pain
Knee
Lead sponsor: Zodiac Produtos Farmaceuticos S.A.
Sponsor class: INDUSTRY
Collaborators: name: Eurotrials Brasil Consultores Cientificos Ltda
First posted: 2015-05-19
Enrollment: 375
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.

Detailed description: Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.

Eligibility criteria: Inclusion Criteria:

* Signs the Informed Consent Form
* Age between 40 and 85 years
* osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology

Exclusion Criteria:

* Cardiovascular disease
* Serious chronic comorbidity
* Hypersensitivity to any component of the study drugs
* body mass index\> 30 kg / m²

Primary outcomes:
measure: Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety measured by frequency of adverse event
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: CRM
name: Edio Costa, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06316999: Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
Official title: Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Pouchitis
Keywords: Ileal Pouch Anal Anastomosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

Detailed description: AIMS:

1. Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
2. Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.

Eligibility criteria: Inclusion Criteria:

* Adults (age ≥ 18 years)
* Diagnosis of ulcerative colitis (UC)
* Status post ileal pouch anal anastomosis IPAA (completed all stages)

Exclusion Criteria:

* Pediatric patients
* Indeterminate colitis
* Status post IPAA for familial adenomatous polyposis (FAP)
* BMI \> 30 kg/m2
* Pregnant
* Decompensated Cirrhosis
* Inability to provide informed consent

Primary outcomes:
measure: Diagnostic accuracy of intestinal ultrasound (IUS) for pouchitis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Darrell Pardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268099: Optimal Timing for Repair of Right-to-Left Shunt Lesions
Official title: Optimal Timing for Repair of Right-to-Left Shunt Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
repair of right to left shunt lesions
Tetralogy of Fallot defects
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 75
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

Brief summary: The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.

The secondary aim being define the criteria for failing medical therapy.

Detailed description: In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.

Study Design and Methodology:

Retrospective chart review - approximately 75 patients

Preoperative data:

Diagnosis

Operative data:

Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared

Postoperative data:

Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications

Eligibility criteria: Inclusion Criteria:

* patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Brian E Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990899: Hypertension and Sleep Disordered Breathing in Pediatrics
Official title: Hypertension and Sleep Disordered Breathing in Pediatrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Obstructive Sleep Apnea
Keywords: hypertension
obstructive sleep apnea
pediatrics
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2009-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children aged 10 to 17 years who have been diagnosed with primary hypertension

Brief summary: The primary objective is to determine the prevalence of sleep disordered breathing in children with primary hypertension or pre hypertension. The secondary objectives are to determine any association factors for children with primary hypertension or prehypertension to have sleep disordered breathing be it gender, age, body mass index (BMI), family history (hx) or ethnic group.

Detailed description: This is an exploratory, cross sectional study involving identification of the children of the age between 10 years and 17 years diagnosed with primary hypertension who have not been previously diagnosed and or treated for sleep disordered breathing with the revised pediatric sleep questionaire (PSQ) for sleep disordered breathing. The subjects that have shown interest will be mailed the informed consent/assent form to tbe reviewed. The consent/assent form will be handed to the child and all their questions and concerns will be answered in a comprehensible manner.

Eligibility criteria: Inclusion Criteria:

* aged 10 to 17 years old diagnosed with primary hypertension

Exclusion Criteria:

* refused to participate in the study
* children to secondary hypertension
* previously diagnosed with sleep disordered breathing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Melodi Pirzada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902199: Tobacco Retraining of Automatic Approach to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders.
Official title: Studying a Novel Intervention, the Tobacco Retraining of Automatic Approach (TRAA), to Treat Individuals With Tobacco Dependence and Severe Concurrent Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tobacco Retraining of Automatic Approach
Placebo Task
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
First posted: 2013-07-18
Enrollment: 0
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: A randomized control trial evaluating a novel smoking cessation intervention in individuals at a an inpatient clinic for clients with addiction and concurrent disorders. The intervention is based on cognitive bias modification, where participants are explicitly or implicitly trained to make avoidance movements by pushing a joystick in response to pictures of smoking, and as a result altering their cognitive biases towards smoking and tobacco dependence.

Hypothesis: Participation in the experimental (tobacco-avoidance) condition will induce reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and 12 week follow-up.


Eligibility criteria: Inclusion Criteria:

* Proficiency to read and write english
* A minimum score of 5 or higher on the fagerström test for nicotine dependence, indicating a medium dependence
* Current smoking will be validated by Carbon monoxide breath monitor

Exclusion Criteria:

* Patients not yet stabilized enough to allow for regular participation in the intervention

Primary outcomes:
measure: Carbon monoxide levels in breath
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Fagerström test for Nicotine dependence (FTND)
timeFrame: Baseline
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: Burnaby Centre for Mental Health and Addiction
state: British Columbia
Study officials:
affiliation: UBC/ VCH
name: Christian Schutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05604599: Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS
Official title: Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Endoscopic Sinus Surgery
Premedication
Analgesia
Keywords: Dexmedetomidine
Intranasal
Intravenous
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.

Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.


Eligibility criteria: Inclusion Criteria:

* Patients older than 21 years of age.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.

Exclusion Criteria:

* Patients with a body mass index \> 30 kg/m2
* Existing or recent significant disease.
* Contraindications to the use of dexmedetomidine.
* History or presence of a significant disease.
* Significant cardiovascular disease risk factors.
* Significant coronary artery disease.
* Any known genetic predisposition.
* History of any kind of drug allergy.
* Drug abuse.
* Psychological or other emotional problems.
* Special diet or lifestyle.
* Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
* Known systemic disease requiring the use of anticoagulants.
* Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
* Patients with a history of previous functional endoscopic sinus surgery.

Primary outcomes:
measure: Improving quality of the operative field.
timeFrame: during surgery (intraoperatively) 2 hours
measure: Amount of atropine consumption
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Hemodynamics(Heart rate (bpm))
timeFrame: 2 hours
measure: Hemodynamics(Mean arterial blood pressure mm Hg))
timeFrame: 2 hours
measure: Pain score
timeFrame: First 24 hours postoperatively
measure: Adverse events
timeFrame: 24 postoperatively
measure: hemostatic stuffing
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Facualty of Medicine(Damietta), Al Azhar University
Study officials:
References: