louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04209439: Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain
Official title: Erector Spinae Plane Block Versus Intravenous Dexketoprofen-trometamol for Treatment of Reno-ureteral Colic: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Colic
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves.

The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications

Primary outcomes:
measure: Number of analgesic consumption
timeFrame: 1 hour
Secondary outcomes:
measure: Numeric Rating Scale
timeFrame: 1 hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ali Ahiskalioglu
Study officials:
References:
citation: Aydin ME, Ahiskalioglu A, Tekin E, Ozkaya F, Ahiskalioglu EO, Bayramoglu A. Relief of refractory renal colic in emergency department: A novel indication for ultrasound guided erector spinae plane block. Am J Emerg Med. 2019 Apr;37(4):794.e1-794.e3. doi: 10.1016/j.ajem.2018.12.042. Epub 2018 Dec 23.
citation: Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: a prospective randomized controlled study. Scand J Urol. 2019 Dec;53(6):411-416. doi: 10.1080/21681805.2019.1658636. Epub 2019 Sep 9.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Clinical trial NCT02163239: Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield
Official title: Post Market Study: Use of the Reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator and the Robotic FloShield System During Robot-assisted Laparoscopic Single-Site Surgery. A Multicenter Historical Control Comparison
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cholecystectomy
Benign Hysterectomy
Salingo-oophorectomy
Keywords: FloShield
MID
Minimally invasive surgery
Minimally Invasive devices
Robot-assisted Laparoscopic Surgery
Single-site Laparoscopic Surgery
Single Incision Laparoscopic Surgery
Cannula
Blunt Obturator
Cholecystectomy
Benign hysterectomy
Salpingo-oophorectomy
Lead sponsor: Minimally Invasive Devices, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited from a population of patients who are from the medical practice of the study investigator and who are scheduled to undergo robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy

Brief summary: This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years or older
* Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator
* Suitable candidate for surgery
* Is able to read and understand the informed consent form and has voluntarily provided written informed consent

Exclusion Criteria:

* Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
* Subjects with known allergy (hypersensitivity) to Docusate Sodium
* Use of Surgiquest AirSeal during the laparoscopic single-site surgery
* Use of humidified insufflation

Primary outcomes:
measure: Completion rate
timeFrame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Secondary outcomes:
measure: Performance
timeFrame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
Study officials:
affiliation: Minimally Invasive Devices
name: Wayne Poll, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01665339: Preload, Weight Management, Risk of Cardiovascular Disease
Official title: Effect of Preload on Body Weight and Cardiovascular Risks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Body Weight
Keywords: preload
anthropometric measures
cardiovascular risk factors
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators presumed that preload consumers will have more weight reduction and lower risk of cardiovascular disease

Detailed description: To our knowledge, all previous studies evaluated the energy intake in a dietary meal after consuming a low-energy-dense preload while none assessed the sustainability of lower amount of energy intake and body weight changes in a long-term. On the other hand, the sustainability of lower energy intake in a long term might be affected by higher dietary diversity score due to considering preload in diets. Notably, increased diet variety is associated with higher overall dietary energy intake and weight gain.

Eligibility criteria: Inclusion Criteria:

* BMI \> 25,
* older than 18 years

Exclusion Criteria:

* poor dietary compliance

Primary outcomes:
measure: the amount of weight reduction in two dietary groups
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Leila Azadbakht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687139: Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
Official title: Study of PSMA-targeted 18F-DCFPyL PET/CT in the Evaluation of Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Kidney Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study the investigators aim to evaluate diagnostic utility of prostate-specific membrane antigen (PSMA)-targeted 18F-DCFPyL PET/CT in patients with renal cell carcinoma (RCC).


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed or histologically proven stage II-IV renal cell carcinoma
* Completed staging evaluation with computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen and pelvis ≤90 days prior to study enrollment

Exclusion Criteria:

* History of other malignancy diagnosed within the last 3 years (with the exception of low risk prostate cancer, ductal carcinoma in situ of the breast, squamous cell carcinoma or basal cell carcinoma of the skin)
* Administered a radioisotope within 5 physical half-lives prior to study enrollment
* Pregnancy ((as determined in accordance with the policies of the positron emission tomography (PET) center))
* Intention to enroll in a blinded therapeutic clinical trial following Positron emission tomography-computed tomography (PET/CT)

Primary outcomes:
measure: Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)
timeFrame: 12 Months
measure: Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mohamad Allaf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.
Clinical trial NCT01151839: A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
Official title: Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Neoplasms
Keywords: Esophagus
squamous cell carcinoma
neoadjuvant chemoradiation
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.


Eligibility criteria: Inclusion Criteria:

1. Age \< 65 years
2. Squamous cell carcinoma
3. Good performance status (Eastern Cooperative Oncology Group \[ECOG\] grades 0, 1 and 2)
4. Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact \<900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
5. No evidence of distant metastasis on CECT.

Exclusion Criteria:

1. Patient refused consent for the study
2. Comorbid conditions which would preclude oesophagectomy

   * Poor performance status (ECOG \> 2)
   * American Society of Anesthesiologists class IV
3. Metastatic disease detected on evaluation
4. Involvement of mediastinal structures except
5. Carcinoma involving cervical esophagus
6. Previous radiotherapy or chemotherapy

Primary outcomes:
measure: Resectability rate
timeFrame: 2 years
measure: postoperative morbidity
timeFrame: 2 Years
measure: operative mortality
timeFrame: 2 Years
Secondary outcomes:
measure: Early disease control
timeFrame: 2 years
measure: Treatment toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Nikhil -, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03768739: Dysphagia and VFMI in Cardiac Patients
Official title: Dysphagia and Vocal Fold Mobility Impairment in Cardiac Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Disease
Keywords: Dysphagia
Extubation
Cardiac Intensive Care Unit (CICU)
Forced Expiratory Volume in One second (FEV1)
Peak Expiratory Flow (PEF)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 230 individuals undergoing cardiothoracic surgery will be enrolled in this study.

Brief summary: The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing cardiothoracic surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

Detailed description: Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiac surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing cardiac surgery. We therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. We also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status.

Eligibility criteria: Inclusion Criteria:

* adults aged 18 - 90 years old
* undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy requiring cardiopulmonary bypass
* willing to participate in post-operative swallowing evaluation testing

Exclusion Criteria:

* Patients undergoing exclusively transcatheter valves
* Patients undergoing exclusively thoracic endovascular aortic repair procedures
* The inability to achieve appropriate alertness and cognitive status following procedure will exclude one from completing the study.
* Participants must pass cognition, respiratory and physical abilities screening to ensure testing safety.

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Baseline
measure: Yale Residue Severity Rating Scale
timeFrame: Baseline; Day 30
measure: Vocal Fold Mobility Impairment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Cardiovascular Clinic at UF Health UF
state: Florida
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
city: Gainesville
country: United States
facility: Thoracic and Cardiovasscular Surgery at UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03658239: Corneal Biomechanics Study
Official title: The Investigation of Corneal Biomechanics Through the Changes in the Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myopia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties.

Detailed description: The preliminary theoretical study in which the corneal geometry at different intraocular pressure (IOP) levels is investigated using a theoretical biomechanical cornea model found changes in both conventional refractive error (sphere and cylinder) and irregular astigmatism i.e. higher order aberrations (e.g. spherical aberration, trefoil and quadrafoil). This is due to the mechanical characteristics of the cornea determined largely by interaction between collagen fibrils organization and extrafibrillar matrix material properties. Corneal geometry and the material properties are the two main factors that contribute to the changes in corneal aberrations with IOP elevation. These aberration changes due to the variation of IOP and the material properties of the cornea can be measured routinely with corneal topography systems (UR) and Brillouin ocular scanner (MGH), respectively and can guide the investigators to study their impact on optical and biomechanical behaviors of the cornea.

Eligibility criteria: Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

* Is an adult between the ages of 18 and 55.
* Is under 250 pounds.

Exclusion Criteria

A person will be excluded from the study if he/she:

* Is under the age of 18 or over the age of 55 yrs.
* Weighs more than 250 pounds.
* Has clinically significant dry eye.
* Has glaucoma.
* Has hypertension.
* Has prior CVA.
* Has cardiovascular disease.
* Has lower extremity joint injury, damage, or replacement.
* Has baseline bradycardia.
* Has any orthopaedic injuries.
* Is pregnant.
* Has hiatal and ventral hernias.
* Has vertigo.
* Has acid reflux (GERD).
* Is undergoing myopia control treatment (e.g. atropinisation, Ortho-K, bifocal contact lenses etc.).
* Has conditions or has undergone procedures resulting in significant corneal irregularity (e.g. keratoconus, corneal transplant, etc.). This does not include astigmatism and basic refractive errors.
* Has any ocular or systemic diseases that, in the opinion of the PI/SI, would interfere with obtaining a measurement.

Primary outcomes:
measure: Corneal Surface Topography Measurement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Rochester
name: Geunyoung Yoon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02819739: Impact of Hyperoxia During Cardiopulmonary
Official title: Impact of Hyperoxia During Cardiopulmonary Bypass in the Occurrence of Cardiovascular Complications After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Complications
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis implies that this work is the use of hyperoxia during cardiopulmonary bypass by his heart preconditioning effect is associated with a lower incidence of cardiac arrhythmias (atrial fibrillation, tachycardia or ventricular fibrillation) and lesions of myocardial ischemia-reperfusion injury in cardiac surgery postoperative.


Eligibility criteria: Inclusion Criteria:

* Major patient ≥ 18 years
* Patient operated cardiac surgery for myocardial revascularization (CABG) or surgical correction of valvular or combined surgery (CABG and valve disease) or ascending aortic surgery
* Signed Consent
* Affiliation to social security

Exclusion Criteria:

* Permanent atrial fibrillation
* Cordarone therapy,
* Pregnant woman
* Patient under guardianship or trusteeship or private public law
* Internal pacemaker
* Hypothermia,
* Patient refusal,
* Cardiac surgery without extracorporal circulation (ECC),
* Participation in another study.

Primary outcomes:
measure: Occurred within 15 days after surgery, disorders of heart rhythm (atrial fibrillation, tachycardia or ventricular fibrillation)
timeFrame: 15 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Dijon
country: France
facility: CHU Dijon-Bourgogne
Study officials:
affiliation: CHU Amiens-Picardie
name: Osama ABOU ARAB, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abou-Arab O, Huette P, Martineau L, Beauvalot C, Beyls C, Josse E, Touati G, Bouchot O, Bouhemad B, Diouf M, Lorne E, Guinot PG. Hyperoxia during cardiopulmonary bypass does not decrease cardiovascular complications following cardiac surgery: the CARDIOX randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1413-1421. doi: 10.1007/s00134-019-05761-4. Epub 2019 Oct 1.
Clinical trial NCT04304339: Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study
Official title: Hypercapnic Acute Respiratory Failure in the ICU : the YETI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Hypercapnia
Acute Respiratory Failure
Lead sponsor: French Society for Intensive Care
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 862
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.

Brief summary: Hypercapnia is a frequent clinical situation defined as an elevation of the partial pressure of carbon dioxide (PaCO2) above 45 mmHg. Several physiopathological parameters such as respiratory minute volume, dead space volume or CO2 production influence the PaCO2. Therefore, hypercapnia can affect the time of various diseases.

Available epidemiological data regarding hypercapnia are from studies investigating the efficacy of non-invasive ventilation (NIV), with different population cohorts. However, their interpretation must be cautious given the heterogeneity in patient case-mix and results.

Then, whether hypercapnia is a common reason for intensive care unit (ICU) admission, epidemiological data is scarce and heterogeneous. The aim of this study is to investigate the epidemiological, clinical determinants and outcomes of patients admitted to ICU with hypercapnic respiratory failure.


Eligibility criteria: Inclusion Criteria:

* patients ≥18 years old presenting with at least of the following items :

  1. respiratory rate ≥ 25/min,
  2. paradoxical motion of the abdomen,
  3. intercostal retraction AND
* a PaCO2 \> 45 cm H20 before ICU admission or within the 12 hours following ICU admission.

Exclusion Criteria:

* Refusal to give informed consent,
* pregnancy,
* \< 18 years patient,
* dying patient

Primary outcomes:
measure: Prevalence of hypercapnic acute respiratory failure in ICU
timeFrame: Intensive Care Unit length stay (Usually 7 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Versailles
country: France
facility: CH Andre Migniot
state: A
city: Nantes
country: France
facility: CHU Nantes
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: