louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00921284: Influence of Dexmedetomidine on a Closed-Loop Anesthesia System
Official title: Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.


Eligibility criteria: Inclusion Criteria:

* male patients scheduled for a general anesthesia

Exclusion Criteria:

* age lower than 18 years
* allergy to propofol, or to soja or to peanuts, or to sufentanil, to remifentanil, or to morphine,or to a myorelaxant or to an excipient,
* hypersensibility to sufentanil, or to remifentanil, or to other derivate of fentanyl,
* history of central nervous system disease,
* patients receiving a psychotropic treatment or an agonist-antagonist opiate,
* hypovolemic patients,
* patients receiving a cardio-vascular treatment,
* expected bleeding surgical procedure,
* simultaneous general and loco-regional anesthesia,
* severe hepatic insufficiency.

Primary outcomes:
measure: administered doses of propofol and of remifentanil during anesthesia
timeFrame: end of anesthesia
Secondary outcomes:
measure: delay before recovery
timeFrame: at the end of anesthesia
measure: hemodynamic abnormalities requiring a treatment
timeFrame: end of anesthesia
measure: postoperative morphine requirement
timeFrame: Third post-anesthetic hour
measure: explicit memorisation
timeFrame: Second postoperative day
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04704284: Comparing MRI to CT on Pediatric Craniosynostosis.
Official title: Comparative Analysis of Zero Echo-time MRI and CT for Pediatric Craniosynostosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Craniosynostosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to develop and test the effectiveness and diagnostic quality of Zero Echo Time Magnetic Resonance Imaging (ZTE MRI) in comparison to CT.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients 0-18 of age will be recruited by our surgical colleagues based on the clinical concern for craniosynostosis and possible need for calvarial reconstruction.

Exclusion Criteria:

* Lack of consent
* Contraindication/inability to undergo both examinations within the designated time period and/or undiagnostic image quality.

Primary outcomes:
measure: Concordance between ZTE and CT imaging diagnosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Julie B Guerin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04618484: Biomodulating Rotator Cuff Healing - A Proof of Concept Trial
Official title: Can Non-pharmacological BIOmodulation Improve Healing After Arthroscopic Rotator Cuff Repair Using a Knotted Suturebridge Technique?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Clinique Générale dAnnecy
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Novel concepts in quantum biology of rotator cuff repair and author's novel findings on biomodulation inspired us to design a pragmatic non-pharmacological add-on rehabilitation protocol that may potentially decrease retear rates after arthroscopic repair using a knotted suturebridge technique. In this proof-of-concept trial, 146 patients will be randomized 1:1 to either a 6-weeks post-operative cryo-, photo- and electro-biomodulation protocol or a control group immobilized in a standard abduction sling for 6 weeks. Healing will be evaluated using the Sugaya classification on MRI at 1 year post-operatively.


Eligibility criteria: Inclusion criteria

* Patient is over 18 years old
* Patient presents with a symptomatic full-thickness tear as diagnosed preoperatively on ultrasound, arthro-CT or MRI.
* Absence of significant muscle atrophy or fatty infiltration of the affected tendon exceeding stage 2 of the Goutallier classification

Exclusion criteria

* Partial rotator cuff tear or other shoulder injury
* Planned concomitant procedures other than subacromial decompression, acromioclavicular joint resection or biceps tenodesis/tenotomy
* Irreparable rotator cuff tear
* Patients who present with cartilage lesions greater than stage II of the Outerbridge classification (≥15mm diameter) on preoperative x-ray
* Patient presenting with a known comorbidity that could affect the outcome of surgery (cervical radiculopathy, polyarthritis, neurological disease of the upper limb)
* Patient not able to give informed consent

Primary outcomes:
measure: Healing of rotator cuff tear
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Patient reported outcome measures
timeFrame: 6 months and 1 year
measure: Active range of motion
timeFrame: 6 months and 1 year
measure: Compliance
timeFrame: First 6 weeks after surgery
measure: Postoperative complications
timeFrame: First year after surgery
Other outcomes:
Locations:
city: Annecy
country: France
facility: Clinique Générale d'Annecy
Study officials:
References:
Clinical trial NCT01428284: A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
Official title: An Open-Label, Fixed-Sequence Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Canagliflozin (JNJ-28431754)
Pharmacokinetic
Probenecid
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 14
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.

Detailed description: This will be a single-center, open-label (identity of study treatments will be known to volunteers participating in the study as well as to study staff) study to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. The study will last up to approximately 49 days (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days when both canagliflozin and probenecid are taken, both doses must be taken at approximately the same time.

Eligibility criteria: Inclusion Criteria: Body mass index (BMI) between 18 and 28 kg/m² inclusive and a body weight of not less than 50 kg. Exclusion Criteria:History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator

Primary outcomes:
measure: Plasma concentrations of Canagliflozin (including canagliflozin metabolites)
timeFrame: Up to Day 18
measure: Plasma concentrations of probenecid
timeFrame: Up to Day 17
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 10 days following Day 18
measure: Clinical Laboratory Tests
timeFrame: Up to 10 days following Day 18
measure: Vital Signs
timeFrame: Up to 10 days following Day 18
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01676584: A Study of Single Dose RO6811135 in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-31
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers. Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135 or placebo subcutaneously.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers, 18 to 45 years of age inclusive
* Body mass index (BMI) 22-32 kg/m2 inclusive
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use adequate contraception as defined by protocol

Exclusion Criteria:

* History or presence of any clinically relevant disease or disorder
* History of drug hypersensitivity or food allergies
* Significant infection or known inflammatory process at screening or Day -1
* Any history of alcohol and/or drug of abuse addiction
* Alcohol consumption of more than 14 units (1 unit = 10 mL of pure alcohol) per week
* Smoking more than 5 cigarettes a day or equivalent amount of tobacco
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug or device study within 3 months prior to screening

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3 months
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration-time curve
timeFrame: Pre-dose and up to 96 hours post-dose
measure: Pharmacodynamics (blood analysis) of RO6811135
timeFrame: 96 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03114384: Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography
Official title: Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diaphragm
Ultrasonography
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 15
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: Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.

These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer (male or female)
* Free and Informed Consent

Exclusion Criteria:

* Known pregnancy, parturient or nursing mother
* Minor under 18 years of age
* Major incapable
* Non-affiliation to the social security scheme
* Any history of respiratory pathology

Primary outcomes:
measure: Asynchronies detection with diaphragm ultrasonography
timeFrame: thirty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Groupe Hospitalier Henri Mondor
Study officials:
References:
Clinical trial NCT05051384: Superb Microvascular Intraocular Tumor Imaging Study (SMITIS)
Official title: Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Tumor
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). Nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. The study of microvascular flow (Superb Microvascular Imaging, SMI) of intraocular tumors could improve the confidence of differential diagnosis when evaluating these suspicious lesions, or even determine whether a lesion is benign or malignant by describing the vascularization of the lesion.

The investigators propose to study the microvascular flow patterns of intraocular tumors prior to proton therapy.

Detailed description: The ultrasound equipment available in ophthalmology does not have Doppler technology and does not allow the study of the vascularization and microvascularization of intraocular lesions. The interest in the system used in this study is to import SMI into ophthalmology to study tumor microvascularization. The study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Intraocular tumor not previously treated with proton therapy

Exclusion Criteria:

* Severe active ocular, periocular or intraocular inflammation
* Intraocular pressure \> 30 mmHg

Primary outcomes:
measure: Qualitative description of the intratumoral microvascular flow
timeFrame: Visite 2 - two weeks after Day 0
measure: Qualitative description of the intratumoral microvascular flow
timeFrame: Month 6
Secondary outcomes:
measure: quantification of microvascular flow for each tumor
timeFrame: Visite 2 2weeks after Day 0
measure: quantification of microvascular flow for each tumor
timeFrame: month 6
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Sacha NAHON ESTEVE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06009484: VTE Incidence After Curative Colon Cancer Surgery in an ERAS Program
Official title: Incidence of Venous Thrombotic Event After Curative Colon Cancer Surgery in an Enhanced Recovery After Surgery Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis, Pulmonary Embolus
Colon Cancer
Keywords: Prolonged thromboembolic prophylaxis
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: Herlev and Gentofte Hospital
name: Hvidovre University Hospital
First posted: 2023-08-24
Enrollment: 2141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective macroradical resection for UICC Stage I-III colonic adenocarcinoma in the Capital Region of Denmark between January 1, 2014, and December 31, 2017. The database does not include acute cases, cases of metachronous colorectal cancers or rectal cancers without synchronous colonic adenocarcinoma.

Brief summary: Based on data on a cohort of 2,141 patients undergoing elective colonic cancer resection in an ERAS program, the incidence of postoperative thromboembolic events is estimated in patients no receiving prolonged thromboembolic prophylaxis.

Detailed description: The Copenhagen cOmplete Mesocolic Excision Study (COMES) database contains comprehensive data on preoperative, intraoperative, postoperative and tumor related variable on patients undergoing elective colonic cancer resection at four public university clinics providing all colorectal cancer treatment for the 1.8 million residents of the Capital Region of Denmark during the period 2014-2017.

None of these hospitals had implemented prolonged thromboembolic prophylaxis after discharge.

The medical records were reviewed with focusing on VTE prophylaxis, ongoing preoperative and postoperative anticoagulant treatment, the length of hospital stay (LOS), and readmission to ensure high data validity.

Eligibility criteria: Inclusion Criteria:

* elective macroradical resection for UICC Stage I-III colonic adenocarcinoma

Exclusion Criteria:

* concomitant rectum resection
* soly appendix carcinoma
* diagnosed with pulmonary embolism or deep venous thrombosis before primary discharge
* dying before discharge from the hospital or discharged at postoperative day 28 or later
* treatment with vitamin K antagonists, heparin or new oral anticoagulants before or after surgery
* VTE less than 3 months before the colon resection

Primary outcomes:
measure: Postoperative venous thromboembolic event
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Copenhagen University Hospital - North Zealand
name: Claus A Bertelsen, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02752984: Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion
Official title: Prospective Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thrombosis
Keywords: Peripherally inserted central venous catheter
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with Peripherally Inserted Central Catheter insertion

Brief summary: Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops.

Detailed description: Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops. Patients will be studied with ultrasound for 4 weeks after PICC insertion, one visit a week. The final outcome of PICCs will be collected.

Eligibility criteria: Inclusion Criteria:

* Peripherally Inserted Central Catheter insertion

Exclusion Criteria:

* Pre-existing Deep Vein Thrombosis

Primary outcomes:
measure: Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination
timeFrame: 4 weeks
Secondary outcomes:
measure: Factors which may be correlated to Deep Vein Thrombosis development: obesity (Body Mass Index)
timeFrame: 4 weeks
measure: Factors which may be correlated to Deep Vein Thrombosis development: cancer
timeFrame: 4 weeks
measure: Factors which may be correlated to Deep Vein Thrombosis development: previous Deep Vein Thrombosis
timeFrame: 4 weeks
measure: Factors which may be correlated to Deep Vein Thrombosis development: Heparin-induced thrombocytopenia
timeFrame: 4 weeks
measure: Overall Deep Vein Thrombosis incidence
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo Pavia
state: PV
Study officials:
affiliation: IRCCS Policlinico San Matteo Pavia
name: Michele Pagani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chopra V, Ratz D, Kuhn L, Lopus T, Lee A, Krein S. Peripherally inserted central catheter-related deep vein thrombosis: contemporary patterns and predictors. J Thromb Haemost. 2014 Jun;12(6):847-54. doi: 10.1111/jth.12549.
citation: Zochios V, Umar I, Simpson N, Jones N. Peripherally inserted central catheter (PICC)-related thrombosis in critically ill patients. J Vasc Access. 2014 Sep-Oct;15(5):329-37. doi: 10.5301/jva.5000239. Epub 2014 Apr 25.