louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06174077: Monitoring of Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Procedures
Official title: Interest of Continuous Monitoring of the Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Gestures With a Flat Panel Detector
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vertebra Compression Fracture
Keywords: Vertebra Compression Fracture
Vertebral cementoplasty
Fluoroscopy time
Fluoroscopic control
Single-level vertebral cementoplasty
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level

Brief summary: The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation.

The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Man or woman
* Patient cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level between 01/06/2020 and 30/09/2020
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Patient who expressed their opposition to the reuse of their data for research purposes
* Vertebroplasties of more than one level
* History of spinal surgery or vertebroplasty near the level concerned

Primary outcomes:
measure: Assess the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00680277: Vitamin A Value of Spirulina Carotenoids in Humans
Official title: Vitamin A Value of Spirulina Carotenoids in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Intrinsically Labeled Spirulina
Keywords: spirulina
carotenoids
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Nestlé Foundation
First posted: 2008-05-20
Enrollment: 20
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this protocol is to determine the vitamin A value (equivalence) of spirulina. The investigation will use intrinsically deuterium labeled spirulina and an isotope vitamin A reference dose, 13C10- retinyl acetate (13C10 RAc), in males (n=20). Up to 45 blood samples (10 ml/sample) will be collected from each subject over a two-month period to evaluate the bioavailability and bioconversion of spirulina ß-carotene to vitamin A.

Detailed description: By utilizing novel stable isotope dilution techniques recently developed in our laboratory, we will trace deuterium labeled ß-carotene in intrinsically labeled spirulina, which is harvested from a hydroponic system. In the mean time, we will track 13C10 labeled vitamin A in humans. In this way we will determine absorption of ß-carotene from spirulina matrix and the conversion of the spirulina ß-Carotene to retinol. This will enable us quantitatively determine the vitamin A equivalence of spirulina.

The specific aims of this study are:

1. To determine labeled ß-C blood response kinetics following an acute dose of intrinsically labeled spirulina;
2. To determine labeled retinol blood response from the intrinsically labeled spirulina;
3. To determine 13C10 retinol blood response from the isotope reference material 13C10 retinyl acetate;
4. To determine s spirulina-vitamin A equivalence.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Not has GI track problems
* Any medical condition that will affect the intestinal absorption

Primary outcomes:
measure: The enrichment of spirulina ß-carotene and its cleavage product vitamin A were tracked after taken the oral dose of intrinsically labeled spirulina.
timeFrame: 51 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: USDA Human Nutrition Research Center on Aging, Tufts Uni.
state: Massachusetts
Study officials:
affiliation: USDA Human Nutrition Research Center on Aging, Tufts University
name: Guangwen Tang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05540847: Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
Official title: Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Neoplasm
Keywords: obturator nerve block
ultrasound guided block
bladder tumor
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 60
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: This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Lateral wall bladder tumour
* ASA I-II patients

Exclusion Criteria:

* Contraindications for spinal anesthesia,
* Tumors that disrupt the integrity of the bladder,
* Coagulation disorders,
* Uncooperative patients,
* Allergy to local anesthetics.

Primary outcomes:
measure: Success rate of obturatr nerve block
timeFrame: Peroperative period
Secondary outcomes:
measure: Number of adductor muscle spazms
timeFrame: Intraoperative period
measure: Sensory block
timeFrame: 30 minutes after the intervention
measure: Patient satisfaction
timeFrame: Peroperative period
measure: Procedure time
timeFrame: During the procedure
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT04919447: Clinical Study of LBBP
Official title: Study of the Efficacy and Safety of Cardiac Pacing of Different Sites
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bradyarrhythmias
Heart Failure
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the current reports and the researcher's pacing implantation status, with an enrollment rate of 90% and a loss of follow-up rate of 10%, it is estimated that 600 cases were screened, 540 cases were selected, and about 500 cases were effective.

Brief summary: At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, you can choose to pace the heart in different parts. The atrium can choose the right atrial appendage, the atrial septum and the right ventricular side wall. The right ventricle can choose to be paced in the His bundle, right ventricular apex and ventricular septal outflow tract. The right ventricle can choose the pacing positions including left bundle branch pacing and left ventricular pacing via coronary vein. There are few studies comparing the long-term efficacy and safety of different pacing programs in daily practice. This study is to observe the short-term and long-term effects and safety of different parts of cardiac pacing, and compare the advantages and disadvantages of different parts of cardiac pacing.


Eligibility criteria: Inclusion Criteria:

* Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.
* Patients who have the ability to understand the test and can cooperate with investigators.

Exclusion Criteria:

* Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors

Primary outcomes:
measure: Composite of Cardiovascular death, myocardial infarction, and stroke events
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaohong Pan
state: Zhejiang
Study officials:
References:
Clinical trial NCT04775147: Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)
Official title: Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome:A Prospective Multicenter Randomized Controlled Trial (CRISIS I)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Mechanical thrombectomy
Blood pressure management
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 205
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: CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.

Detailed description: CRISIS I aims to determine the effectiveness of more intensive BP lowering target (\<120 mmHg) compared to standard BP management target (\<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging
* To receive MT \<24 hours after AIS onset according to local guidelines
* Successful recanalization (TICI score ≥2b) after MT
* Sustained systolic BP ≥140 mmHg (defined as 2 successive readings \<10 mins) within 60 minutes after recanalization
* Provide written informed consent (or approved surrogate)
* Perform CTA or MRI before endovascular therapy
* Signed an approved informed consents

Exclusion Criteria:

* Significant pre-stroke disability (mRS scores 2-5)
* Definite indication/contraindication to different intensities of BP lowering treatment
* Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients)
* Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician
* Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating
* Other conditions inappropriate for inclusion judged by investigators

Primary outcomes:
measure: Level of disability
timeFrame: 90 days (3months)
Secondary outcomes:
measure: Intracerebral hemorrhage
timeFrame: 90 day
measure: Death or neurological severity
timeFrame: 7 days
measure: BP lowering target (<120 mmHg)
timeFrame: 3 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01622647: The Effect of Nasal Continuous Positive Airway Pressure (N-CPAP) on Arterial pCO2 During Spinal Anesthesia
Official title: The Effect of Nasal Continuous Positive Airway Pressure (N-CPAP) on Arterial pCO2 During Spinal Anesthesia With Intravenous Sedation for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Replacement Surgery
Keywords: NCPAP
Lead sponsor: Pediatrix
Sponsor class: OTHER
Collaborators: name: New Hanover Regional Medical Center
name: American Anesthesiology of the Carolinas
First posted: 2012-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study intends to investigate several aspects of the respiratory effects of intravenous sedation of patients undergoing spinal anesthesia for knee replacement surgery. The study will include assessment of PaCO2 during the intraoperative period. PaCO2 is expected to be elevated as a result of intravenous sedation and postural factors. Further, the study will investigate how application of Nasal Continuous Positive Airway Pressure (N-CPAP) may impact PaCO2.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology Class I, II, or III patients
* Age over 21 years and under 70 years
* Planned surgical procedure is total knee arthroplasty (TKA) to be performed at Cape Fear Hospital
* Body Mass Index less than 40
* The patient and their attending anesthesiologist select spinal anesthesia with intravenous sedation, intrathecal morphine, and femoral nerve block as the preferred anesthesia plan

Exclusion Criteria:

* Prior diagnosis of Obstructive Sleep Apnea based upon sleep study
* History of Stroke with residual neurologic deficit
* Prior diagnosis of Emphysema, Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, or Asthma, or other chronic lung disease
* Recent history of significant nasal obstruction, epistaxis, or facial abnormality that may interfere with proper fit of a nasal CPAP mask
* Pregnancy
* Mental or other disability preventing a patient from personally giving informed consent
* Chronic narcotic or benzodiazepine treatment or dependency
* Allergy to Midazolam, Fentanyl, or Propofol
* Severe upper respiratory infection within the past three weeks

Primary outcomes:
measure: Arterial Blood Gas (ABG) test to investigate the breathing effects on patients receiving CPAP treatment during spinal anesthesia for knee replacement.
timeFrame: ABG will be collected five minutes after surgical skin incision and the second specimen will be collected exactly 30 minutes later.
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
Study officials:
affiliation: American Anesthesiology of the Carolinas
name: Stephen B Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01536847: Glycaemic Response Testing
Official title: Glycaemic Response Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycaemic Index
Glycaemic Response
Lead sponsor: Mondelēz International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Reading Scientific Services Ltd.
First posted: 2012-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).


Eligibility criteria: Inclusion Criteria:

* Male or female (not less than 40% males or females
* Non-smoker
* Aged 18 to 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Having a fasting plasma glucose (finger stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent

Primary outcomes:
measure: Glycaemic index of experimental test food using capillary blood
timeFrame: 0-120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: RSSL
name: Suzana Louth, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01295047: Comparison of Medical Therapies in Marfan Syndrome.
Official title: Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Marfan Syndrome
Keywords: Marfan Syndrome
Large arterial function
LV function
atenolol
perindopril
verapamil
central arterial pressure
Lead sponsor: Cardiff University
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are looking at the different impacts of atenolol, verapamil and perindopril on large artery and lv function in marfan syndrome. It is a double-blind, randomised cross-over trial.

Detailed description: The investigators recruited 21 patients with confirmed diagnosis of Marfan syndrome from two centres. The investigators performed radial artery applanation tonometry and pulse wave analysis to derive central aortic pressure and haemodynamic indexes pre-and post administering Atenolol 75mg, Perindopril 4mg and Verapamil 240mgs each for four weeks with a two week wash-out between medications. All patients underwent detailed functional and anatomical echocardiographic assessments at each visit.

Inclusion criteria were ages 16-60 years with no treatment or β-blocker or other monotherapy only for Marfan syndrome. Patients with previous aortic dissection or aortic surgery, severe valvular regurgitation, aortic diameter at the sinotubular junction ≥ 5.0cm, contraindications to specific drug treatment, e.g. asthma and β-blocker, or those who were pregnant or at risk of pregnancy were excluded.

Eligibility criteria: Inclusion Criteria:

* Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome

Exclusion Criteria:

* Previous aortic dissection or aortic surgery
* Severe valvular regurgitation
* Aortic diameter at the sinotubular junction ≥ 5.0cm
* Contraindications to specific drug treatment, e.g. asthma and β-blocker
* Those who were pregnant or at risk of pregnancy

Primary outcomes:
measure: CENTRAL ARTERIAL PRESSURE
timeFrame: 18 weeks
Secondary outcomes:
measure: LARGE ARTERIAL STIFFNESS INDICES
timeFrame: 18 WEEKS
measure: LV Function
timeFrame: 18 WEEKS
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Wales Heart Research Institute, Cardiff University
Study officials:
References:
Clinical trial NCT05569447: Tree Branch Penetrating Injury
Official title: Tree Branch Penetrating Injury Into Zone III of the Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penetrating Injury Neck
Lead sponsor: South Texas Health System McAllen
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 1
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Trauma penetrating injury to the neck

Brief summary: Penetrating trauma to the neck can result in severe morbidity and mortality. Location of the injury dictates the appropriate clinical management. Challenging traumatic injuries require resourceful treatment options

Detailed description: A complex traumatic case of a foreign body penetrating the neck, the parotid gland, disrupting the internal jugular vein, with the tip resting at the anterior aspect of the C1 ring is reported. In this case, the authors seek to describe the clinical management of a vascular injury that resulted from penetrating zone III of the neck.

Due to the complex and dense presence of various structure in the neck, injuries can be difficult to manage. Thus, an algorithm identifies management strategies that are suggested based on the location of the injury, signs of vascular injury, identified injured structures and the hemodynamic stability of the patient. Balloon tamponade has been described in other organs of the body and it might be a therapeuticn option in patients were venous injuries are difficult to access.

Penetrating neck injuries continue to result in significant morbidity and mortality. However, with appropriate and efficient evaluation and management, better outcomes are expected as demonstrated in this case.

Eligibility criteria: Inclusion Criteria:

* Penetrating Injury to the Neck

Exclusion Criteria:

* N?A

Primary outcomes:
measure: Mortality
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: McAllen
country: United States
facility: STHS McAllen
state: Texas
Study officials:
References: