louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00897832: Biomarkers in Predicting Response to Treatment in Patients Who Have Undergone Surgery for Pancreatic Cancer
Official title: Developing Predictive Markers of Therapeutic Response in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cancer

Brief summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers in predicting response to treatment in patients who have undergone surgery for pancreatic cancer.

Detailed description: OBJECTIVES:

* To determine if a method of extracting and identifying biomarkers (i.e., secreted cytokines and growth factors) from tissues of the quantity obtained from typical biopsy can now be applied in the setting of pancreatic cancer
* To correlate pre-treatment biomarkers with recurrence, overall survival, and tumor response to radiotherapy and chemotherapy in patients with pancreatic cancer.

OUTLINE: Tumor tissue specimens are obtained from the Vanderbilt Ingram Cancer Center Human Tissue Acquisition Core and analyzed for biomarkers (e.g., integrity of DNA repair pathways as analyzed by Rad51 and phosphorylated DNA-PK foci formation). The biomarkers are correlated with clinical outcomes (recurrence, overall survival, and tumor response to treatment).

Patients are followed for recurrence, relapse, and death from disease.

Eligibility criteria: Inclusion criteria

* Diagnosis of pancreatic cancer
* Excess tissue collected at the time of routine surgery for pancreatic cancer must be available for analysis

Exclusion criteria

* None known

Primary outcomes:
measure: Determination if a method of extracting and identifying biomarkers from tissues of the quantity obtained from typical biopsy can be applied in the setting of pancreatic cancer
timeFrame: 1 year following final patient data
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: A. Bapsi Chakravarthy, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05614232: Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray
Official title: Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease
Lead sponsor: Lunit Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 700
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Secondary hospital patient

Brief summary: This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities

Detailed description: In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.

Eligibility criteria: Inclusion Criteria:

* Chest radiographs of aged 14 years or older
* Conventional PA or AP chest radiographs
* Chest radiographs with confirmed radiology reports

Exclusion Criteria:

* Chest radiographs taken in postures other than PA and AP
* Chest radiographs from dual-energy radiography
* Invert-grayscale chest radiographs

Primary outcomes:
measure: the effectiveness of the investigational device
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT04309032: A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction
Official title: A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retrograde Bladder Fill
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 54
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial on the effect of retrograde partial bladder fill on time to discharge in patients who have had urological surgery for BPH, and whether it affects overall medical staff satisfaction.


Eligibility criteria: Inclusion Criteria:

* Any male patient between ages 20-80 with foley catheter indwelled after urological surgery performed at our institution

Exclusion Criteria:

* Any patient that does not remove foley catheter at discharge

Primary outcomes:
measure: Time to void
timeFrame: 1day
measure: Time to discharge
timeFrame: 1day
measure: Medical staff satisfaction
timeFrame: 1year
measure: Patient satisfaction
timeFrame: 1day
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hakmin Lee, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05356832: Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence
Official title: Investigation of the Relationship Between Pelvic Floor Awareness and Urinary Incontinence in Young Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Floor
Urinary Incontinence
Young Athletes
Keywords: pelvic floor
awareness
knowledge
urinary incontinence
athletes
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young athletes studying at Süleyman Demirel University, Faculty of Sport Sciences

Brief summary: There is no study in the literature examining the knowledge level and urinary symptoms of active athletes about the pelvic floor. The aim of this study is to determine the relationship between PTC awareness and incontinence in young athletes who engage in long-term and high-intensity activities that increase the risk of SUI.


Eligibility criteria: Inclusion Criteria:

18-25 years old Young athletes

Exclusion Criteria:

Having a neurological disorders

Primary outcomes:
measure: International Physical Activity Questionnaire- Short Form
timeFrame: baseline
measure: Pelvic Floor Health Knowledge Quiz
timeFrame: baseline
measure: International Urinary Incontinence Consultation Questionnaire-Short Form (ICIQ-SF)
timeFrame: baseline
measure: Incontinence Impact Questionnaire-7
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
Study officials:
affiliation: Suleyman Demirel University
name: Pinar YASAR
role: STUDY_DIRECTOR
References:
Clinical trial NCT03683732: EXTENSION OF THE EUROPEAN E-BUG PROJECT
Official title: EXTENSION OF THE EUROPEAN E-BUG PROJECT TOWARDS 15-18 YEARS - How to Raise Awareness About Antibiotics and Vaccination Among Frenchteenagers -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination Failure
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recrutement and the conversations were realized on a voluntary basis in the crossroads health young people of Nice, structure dedicated to the grown-up young adolescentset from 12 to 25 years old.

Brief summary: Bacterial resistance to antibiotics is a growing concern in Europe, vaccination coverage is inadequate, and young adults, who are the highest antibiotic consumers, have the lowest level of knowledge. Extension of the e-Bug project, a European educational school programme concerning microbes, antibiotics and vaccination, to 15-18-year-olds implies the development of educational resources based on social marketing to promote sustainable behavioural changes. The objectives of the present study, which is part of the needs assessment in France, are to explore the attitudes, knowledge and behaviour of 15-18-year-olds concerning antibiotics and vaccination and their health education needs.

Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed.


Eligibility criteria: Inclusion Criteria:

* 15-18 year olds, various origines, studying in various pathways of higher secondary education or working.

Exclusion Criteria:

-

Primary outcomes:
measure: Behavior concerning antibiotics and vaccination
timeFrame: 5 years
Secondary outcomes:
measure: Expectation and media
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Pia Touboul, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT01010932: Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Official title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Arterial Diseases
Keywords: carotid or vertebral artery disease
Contrast agent
MRA
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed description: Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged more than 18 years
* Strongly suspected of having carotid or vertebral arterial disease
* Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Primary outcomes:
measure: Technical Failure Rate
timeFrame: 2 - 28 days
measure: Sensitivity
timeFrame: 2-42 days
measure: Specificity
timeFrame: 2 - 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Guerbet LLC
state: Indiana
Study officials:
affiliation: Guerbet
name: Pierre DESCHE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05954832: A Study of Changes in Heart Function and Blood Flow in People Receiving Anesthesia
Official title: Changes in Loading Conditions on Induction of General Anesthesia: Mechanisms of Post-Induction Hypotension (PIH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Keywords: Changes in Heart Function
Changes in Blood Flow
Echocardiography
23-079
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 250
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: Adult patients requiring general anesthesia for surgery

Brief summary: The purpose of this study is to understand changes in heart function (how the heart pumps blood) and blood flow in people who receive general anesthesia during surgery. The researchers are particularly interested in the heart function and blood flow changes in people who experience low blood pressure (hypotension) after receiving anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years of age requiring general anesthesia for surgery
* Intubation required for anesthetic management / surgery
* Anticipated prep time before incision of 20 minutes
* Baseline MAP \>70mmHg

Exclusion Criteria:

* History of coronary artery disease
* History of cardiac disease (e.g., HTN, arrythmias, valvular and structural abnormalities)
* History of peripheral artery occlusive disease
* Beta-blocker use
* Anti-hypertensive medication use
* Patients with epidural, spinal, paravertebral, serratus blocks preoperatively
* Patients requiring rapid sequence induction (where intubation occurs concurrently with induction)
* Emergency surgery

Primary outcomes:
measure: The proportion of patients with post-induction hypotension (PIH)
timeFrame: up to 20-mins after anesthesia induction.
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anahita Dabo-Trubelja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01436032: Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery
Official title: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Intravenous N1539 in Subjects After Abdominal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Laparoscopic Surgery
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Planning to undergo elective abdominal laparoscopic surgery involving a single site/organ and does not have intraperitoneal metastases suspected or identified

Exclusion Criteria:

* Use of ketorolac is contraindicated
* Use of general anesthesia is contraindicated
* Has a medical condition that could adversely impact subject participation
* Has diabetes mellitus and glycosylated hemoglobin (HbA1c) \>9.5 or history of prolonged uncontrolled diabetes
* Body mass index (BMI) less than 18 or greater than 35
* Has a history of intolerance or allergic reactions to non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors, aspirin or other salicylates
* Known or suspected sleep apnea
* History of Hepatitis B or C
* Has a psychiatric disorder that impairs capability of subject to report pain
* Known to have chronic obstructive pulmonary disease (COPD) with carbon dioxide retention or chronic hypoxemia

Primary outcomes:
measure: Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24)
timeFrame: 0 to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research LLC
state: California
Study officials:
affiliation: Lotus Clinical Research, LLC
name: Neil Singla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
Clinical trial NCT01329432: Surfactant Administration During Spontaneous Breathing
Official title: Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumothorax
Pulmonary Interstitial Emphysema
Bronchopulmonary Dysplasia
Keywords: surfactant
intubation
spontaneous breathing
bronchopulmonary dysplasia
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 100
Sex: ALL
Minimum age (years): 23
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.

Detailed description: In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing. In the control group infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. The procedures were compared for short-term efficacy and possible complications.

Eligibility criteria: Inclusion Criteria:

* All infants who presented with clinical anl laboratory signs of RDS

Exclusion Criteria:

* infants who required intubation or PPV right after birth

Primary outcomes:
measure: nasal cPAP failure and need for mechanical ventilation within 72 hours
timeFrame: first 72 hours
Secondary outcomes:
measure: incidence of bronchopulmonary dysplasia
timeFrame: 8-10 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit
Study officials:
References:
citation: Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.
Clinical trial NCT01892332: The Effective Concentration of Lidocaine With Fentanyl in Lumbar Epidural Anesthesia for Transurethral Resection of Prostate(TURP) in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH( Benign Prostate Hyperplasia)
TURP(Transurethral Resection of Prostate)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 20
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Epidural lidocaine is widely used in anesthesia for urologic or lower abdominal surgery because of its rapid onset. But the epidural anesthesia using high concentration of lidocaine may cause excessive motor block and unwanted side effects such as nausea, vomiting and hypotension.

This is a study to determine the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate in elderly patients.


Eligibility criteria: Inclusion Criteria:

* ASA 1 -3, patients scheduled for TURP( transurethral resection of prostate) were included

Exclusion Criteria:

* Patients with any contraindication to epidural anesthesia were excluded.

  * cognitive impairment
  * coagulopathy
  * allergy to lidocaine
  * infection at the puncture site

Primary outcomes:
measure: Determining the effective concentration of lidocaine with fentanyl in lumbar epidural anesthesia for transurethral resection of prostate(TURP) in elderly patients
timeFrame: A blinded Assistant assess sensory and motor blockade in a 2-min intervals up to 60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: