louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00640380: A Comparison Between Neurostimulation and Loss of Resistance for Cervical Paravertebral Blocks
Official title: A Comparison Between Neurostimulation and Loss of Resistance for Cervical Paravertebral Blocks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Surgery
Keywords: cervical
paravertebral
block
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Cervical paravertebral blocks (CPVBs) target the brachial plexus from a puncture site situated in the posterior aspect of the neck and represent an alternative to interscalene blocks (ISBs) for shoulder and proximal humeral surgery. Randomized controlled trials comparing CPVB and ISB have found no significant differences in success rate, onset and offset times. Because of the reliability of their cutaneous landmarks, CPVBs have become part of the investigators' standard practice. With this approach, the brachial approach can be identified either with loss of resistance to air (LOR) or nerve stimulation (NS). While some authors have used only LOR and reported good success rates, others have hypothesized that NS may increase the reliability of the block. In the proposed study, for the first time, the 2 methods will be formally compared.


Eligibility criteria: Inclusion Criteria are:

* age between 18 and 70 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 28

Exclusion criteria are:

* adults who are unable to give their own consent
* pre-existing obstructive or restrictive lung disease (assessed by history and physical examination)
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets≤ 100, International Normalized Ratio≥ 1.4 or prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases≥ 100)
* allergy to local anesthetic agents (LA)
* pregnancy
* prior cervical spine surgery

Primary outcomes:
measure: Success
timeFrame: 8 months
Secondary outcomes:
measure: performance time, onset time, side effects
timeFrame: 8 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: De QH Tran, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04865380: Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
Official title: Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair: A Double Blinded, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Subacromial Impingement
Subacromial Impingement Syndrome
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure.


Eligibility criteria: Inclusion Criteria:

* Age 18-100
* Male and Female
* Patient able to read and understand consent form
* Non-traumatic, simple small or medium sized rotator cuff tear as defined by pre-operative MRI
* Booked to operating room for elective rotator cuff repair
* Beach chair positioning

Exclusion Criteria:

* Patient refusal to participate
* Massive rotator cuff tear
* Acute traumatic rotator cuff tear
* Known coagulopathy
* Patients with a history or risk of thromboembolism
* Known hypersensitivity to tranexamic acid
* Patient unable to be off anti-coagulant medication for long enough to counter effects
* Patient has a clinic systolic blood pressure \> 150mmHg
* Lateral positioning
* Requirement or insistence by patient or anesthesiologist on regional block
* Patients who have smoked nicotine products within the last year
* The presence of other inflammatory conditions (calcific tendonitis, rheumatoid arthritis, etc.)
* The presence of active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis
* Patient has a seizure disorder
* Patients on medications identified as having drug-drug interactions (hormonal contraceptive, hydrochlorothiazide, desmopressin, sulbactam-ampicilllin, carbazochrome, ranitidine, or nitroglycerine
* Patient is pregnant
* Patients with history of subarachnoid hemorrhage
* Patients with renal insufficiency
* Patients with acquired disturbances of color vision

Primary outcomes:
measure: Arthroscopic Visualization Score
timeFrame: Surgeon will complete the visualization score immediately after the surgery is completed.
Secondary outcomes:
Other outcomes:
Locations:
city: White City
country: Canada
facility: Dash & Reed Sports Medicine
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Jeremy Reed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07022080: Evaluating the Effectiveness of 68Ga-grazytracer PET/CT in Inflammatory Bowel Disease
Official title: 68Ga-grazytracer PET/CT Study in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases (IBD)
Keywords: PET/CT
68Ga-grazytracer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-centre, prospective, observational cohort study in which 69 patients with inflammatory bowel disease (IBD) were recruited to undergo 68Ga-grazytracer PET/CT imaging in patients with IBD to investigate the feasibility of early sensitive detection or prediction of the response to medication in patients with inflammatory bowel disease on 68Ga-grazytracer PET/CT and early prediction of the The feasibility of 68Ga-grazytracer PET/CT for early detection or prediction of response to drug therapy and early prediction of long-term prognosis in patients with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years old; Clinical diagnosis of inflammatory bowel disease (active stage); Not having received treatment within 4 weeks prior to undergoing PET/CT examination; Received endoscopy within 7 days before and after PET/CT examination; Signing an informed consent form for PET/CT examination and volunteering to participate in this study.

Exclusion Criteria:

* No signed informed consent or unspecified diagnosis; Female subjects are pregnant or breastfeeding and male subjects are preparing for pregnancy; Those who are unfit to perform (concomitant severe and/or uncontrollable and/or unstable disease, developer allergy) or who are unable to complete imaging such as PET for specific reasons (needle-sickness, blood-sickness, claustrophobia); Colitis other than inflammatory bowel disease (infectious or ischaemic colitis); Patients who have undergone colon resection.

Primary outcomes:
measure: Maximum Standardized uptake value
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province
state: Shaanxi
Study officials:
References:
Clinical trial NCT03005080: Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease
Official title: The Utility of Pharmacogenetic Testing in Managing Children With Persistent Gastroesophageal Reflux Disease Despite Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-12-29
Enrollment: 51
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children \<18 years of age

Brief summary: This study will use a 22 gene pharmacogenomics panel on 30 children with persistent Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.

Detailed description: This study will assess the clinical utility of pharmacogenomics testing in the clinical management of children with refractory GERD, despite adequate therapy and the role of pharmacogenomics in selecting the right acid suppressive therapy based on each patient's symptoms and pharmacogenomics results.

Eligibility criteria: Inclusion Criteria:

* persistent gastrointestinal symptoms (GI) suggestive of gastro esophageal reflux disease (GERD) despite adequate therapy
* persistent evidence of abnormal reflux indices' and acid exposure on esophageal multichannel pH impedance study despite adequate therapy
* persistent endoscopic evidence of reflux esophageal disease despite adequate therapy

Exclusion Criteria:

* children with eosinophilic esophagitis diagnosis
* children with any esophageal surgical intervention like fundoplication, tracheoespahgeal fistula repair or esophageal atresia repair
* children with other diseases that can affect the esophagus, like Crohn's disease or food protein-induced enterocolitis syndrome (F-PIES)
* Children who do not have research authorization in their chart

Primary outcomes:
measure: Number of subjects who change medication due to pharmacogenomic results
timeFrame: 12 weeks
measure: Number of subjects who have a repeat scope
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT03994380: Use of DNAse in Neutrophilic Asthma
Official title: Use of DNAse in Neutrophilic Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neutrophilic Asthma
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this pilot protocol, the researchers look to determine benefits from use of nebulized rh-DNase for 4 weeks in patients with neutrophilic asthma.

Detailed description: Patients with asthma of a non-Th2 phenotype have few advanced therapeutic options if their asthma remains poorly controlled despite adherence to guideline-based therapy. Currently, no targeted biologic therapies are available for neutrophilic asthma. The role of Recombinant human deoxyriboneuclease (rhDNase) has not been investigated in refractory asthma. rhDNase cleaves extracellular DNA released by neutrophils and other granulocytes, thereby reducing the viscosity of mucus. It is known that patients with asthma have higher levels of extracellular DNA than normals; however, these levels are lower than DNA levels found in the sputum of patients with cystic fibrosis. The benefits of rhDNase in cystic fibrosis have been well described. In these patients, use of daily nebulized rhDNase has shown improvement in lung function and reduction in exacerbations. Very little is known about DNAse use in asthmatics. Case reports have shown benefit when used in acute asthma exacerbations, but there are no data on its use as a therapy for neutrophilic asthma.

Eligibility criteria: Inclusion Criteria:

* i. Able to read and sign an Informed Consent Form (ICF)
* ii. At least Age 18
* iii. Diagnosis of Asthma with previous source documentation of PC 20 ≤ 16 mg/dl measured by FEV1 and/or reversibility with albuterol of ≥12% in FEV1
* iv. pre-bronchodilator Forced Vital Capacity (FVC) less than 85% predicted AND Serum total MMP9 ≥ 1800 (cut off determined by previous clinical investigation- Medimmune) OR serum IL-8\> 20 pg/ml OR Sputum extracellular DNA ≥ 3.8 µg/mL OR Sputum Neutrophils \> 40%

Exclusion Criteria:

* i. Pregnancy
* ii. Current smoker, smoking within the past year or pack/year history ≥ 10
* iii. Respiratory infection within past 6 weeks
* iv. Antibiotics within the past 4 weeks
* v. Active lung disease other than asthma
* vi. Cancer within the past 5 years (excluding basal cell skin cancer)
* vii. Chronic infection due to HIV, HBV, or HCV
* viii. Hematologic or autoimmune disease
* ix. Unable to safely undergo bronchoscopy as determined by primary or study doctor.

Primary outcomes:
measure: Lung Function
timeFrame: 4 weeks
measure: Symptom Control
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References:
Clinical trial NCT03116880: In Vivo Evaluation of Image Registration Techniques During Endovascular Repair
Official title: In Vivo Evaluation of Image Registration Techniques During Endovascular Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Keywords: Aorta, Abdominal/surgery
Endovascular Procedures
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2017-04-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endovascular aortic repair at St. Olav Hospital, Trondheim, Norway

Brief summary: Fluoroscopy is traditionally used for guidance of endovascular aortic repair (EVAR). In order to minimize exposure to radiation and nephrotoxic contrast medium, it is possible to generate a navigation road map by registering the intraoperative images with preoperative computed tomography angiograph (CTA). In modern hybrid operating rooms, several commercial solutions for this exists today (e.g. Siemens Syngo iPilot, Phillips Vesselnavigator). In order to register (fuse) the preoperative and intraoperative imaging to each other, a registration algorithm has to be applied. Sufficient accuracy of this algorithm is crucial, for if it fails the road map cannot be used for intraoperative navigation. The purpose of this study is therefore to evaluate two different 3D registration algorithms with regard to registration accuracy.

Detailed description: Two different registration algorithms will be tested:

1. registration algorithm - centerline registration algorithm (Sintef, Trondheim) A catheter equipped with a position sensor records the travelled path of the instrument, which is assumed to be close to the centerline of the aorta. From the preoperative computer tomography scan (CT) the aorta is segmented and vessel centerline is extracted. The centerline from the position sensor recordings is registered to the extracted centerline of the preoperative CT.
2. 3D-3D registration algorithm (Syngo iPilot, Siemens Medical Solutions, Munich). Intraoperative cone-beam-CT (CBCT) is registered to the preoperative CT

Eligibility criteria: Inclusion Criteria:

* infrarenal or juxtarenal abdominal aortic aneurysm
* undergoing EVAR
* informed consent

Exclusion Criteria:

* under 18 years

Primary outcomes:
measure: Registration accuracy of registration algorithms
timeFrame: Immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs hospital
Study officials:
affiliation: Norwegian University of Science and Technology, Department of Circulation and Medical Imaging
name: Øystein Risa
role: STUDY_DIRECTOR
References:
Clinical trial NCT04132180: Early Versus Late Upper Extremity Mobilization After Autograft
Official title: The EXTREMA Trial: The Impact of Early Versus Late Upper Extremity Mobilization After Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 2
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: Rationale: There is currently no observational study or randomized clinical trial published evaluating the impact of early versus late mobilization in the upper extremity after split thickness skin autograft. As the current post-operative care protocols vary based on physician preference, evidence is needed to optimize post-operative rehabilitation protocols guided by evidence which optimize wound healing, extremity range of motion, graft site pain, as well as minimize risks of complications and length of stay in hospital.

Objective: To determine if early mobilization is non-inferior to late mobilization of the upper extremity after split thickness skin autograft with regards to wound healing measured as percent graft take on post-operative day 5 in adult burn patients.


Eligibility criteria: Inclusion Criteria:

1. 18 years and older at the time of surgery.
2. Injury: Acute (within 72h of injury) thermal flame or scald burn.
3. Surgery: Skin split-thickness meshed autograft (STSG) applied directly on the wound bed.
4. Location: Upper extremity burn - distal to the axilla and proximal to the wrist.

Exclusion Criteria:

1. Injury: Electrical and chemical burn.
2. Location: Autograft exclusively to the wrist, hand, axilla or non-upper extremity.
3. Patients on vasopressors the day of the operation.
4. Pre-existing comorbidities causing upper extremity mobility restrictions.
5. Patient unable to comply with mobilization protocol.

Primary outcomes:
measure: Wound healing
timeFrame: Post-operative day 5
Secondary outcomes:
measure: Wound healing
timeFrame: Post-operative day 14
measure: Post-operative clinical outcomes
timeFrame: Post-operative day 5 and 14
measure: Post-operative clinical outcomes
timeFrame: Post-operative day 5 and 14
measure: Post-operative complications
timeFrame: Acute hospital stay, up to one year
measure: Discharge outcome - disposition
timeFrame: Acute hospital stay, up to one year
measure: Discharge outcome - readiness
timeFrame: Acute hospital stay, up to one year
measure: Discharge outcome - length of stay
timeFrame: Acute hospital stay, up to one year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT03651180: Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts
Official title: Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts: a Cross-sectional Multicentre Consecutive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Diabetes Mellitus
Keywords: Polymer free drug eluting stent
Lead sponsor: Ospedale S. Giovanni Bosco
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 3400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All diabetic patients undergone percutaneous coronary intervention with insertion of drug eluting stents

Brief summary: More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. However, to date there are no direct comparisons of these two type of drug eluting stents.

Detailed description: Drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have major adverse event despite this treatment. More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. These more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.

Eligibility criteria: Inclusion Criteria:

* diagnosis of insulin or non-insulin dependent diabetes mellitus treated from at least 1 month
* if basal blood sugar at the admission is above 200 mg / dl or hemoglobin levels glycated\> 6.5% (\> 48 mmol / mol)

Exclusion Criteria:

* inability to provide informed consent or unable to guarantee the possibility of be contacted in the following 12 months;
* age under 18 years or over 80 years

Primary outcomes:
measure: Incidence of the composite endpoint of cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding in the two groups of study
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of every single adverse event (cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding) in the two groups of study
timeFrame: 1 year
Other outcomes:
Locations:
city: Turin
country: Italy
facility: San Giovanni Bosco Hospital - ASL Città di Torino
Study officials:
affiliation: San Giovanni Bosco Hospital - ASL Città di Torino
name: Salvatore Colangelo, MD
role: PRINCIPAL_INVESTIGATOR
References: