louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05710601: Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
Official title: Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Gynecologic Neoplasm
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred from the outpatient gynecological clinics of our unit who, according to national and international treatment guidelines, were eligible for a planned laparoscopic surgery.

Brief summary: The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills.

The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy.

Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.


Eligibility criteria: Inclusion Criteria:

* Senior gynecological surgeons
* At least 4 years of residency in gynecology

Exclusion Criteria:

* Junior residents, fellows, consultants
* Operative procedures due to malignancy
* Women who were not suitable for or denied a laparoscopic approach
* Declined the procedure
* Did not sign a written informed consent form
* Suffering from a gynecologic malignant disease or severe systemic illnesses
* Laparotomic conversion

Primary outcomes:
measure: Vision of the surgical field
timeFrame: 7 days
measure: Interpretation of the difficulty of the intervention
timeFrame: 7 days
Secondary outcomes:
measure: Overall procedural satisfaction
timeFrame: 7 days
measure: Procedure time
timeFrame: Procedure
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT01684501: Comparing Active and Passive Ankle-foot Prostheses
Official title: Comparing Active and Passive Ankle-foot Prostheses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trans-tibial Amputation
Keywords: prosthesis
amputees
gait
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with history of traumatic unilateral transtibial amputation

Brief summary: The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

Detailed description: Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

Eligibility criteria: Inclusion Criteria:

* weigh more than 200 lbs
* are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade
* have the ability to follow multi-step commands.

Exclusion Criteria:

* score level D on the SIGAM mobility grade
* have experienced 1 or more falls in the last month before the study
* have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot
* the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function
* the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity
* Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation

Primary outcomes:
measure: Ankle power generation
timeFrame: During the session trial (approx 10 minutes)
Secondary outcomes:
measure: Metabolic cost of ambulation
timeFrame: During the session trial (approx 10 minutes)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital Boston
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03074201: Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
Official title: Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis
Biliary Obstruction
Keywords: ERCP, choledocholithiasis, cholangioscopy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2017-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective feasibility study to evaluate potential for cholangioscopy to facilitate radiation-free ERCP.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Prospective Evaluation of the Ability of Spyglass Cholangioscopy to Facilitate Radiation Free ERCP for non-complex bile duct stone disease.


Eligibility criteria: Inclusion Criteria:

1. Age 18 and above
2. Non-complex biliary stone disease involving stones in the common bile or common hepatic duct.
3. Patient has undergone non-invasive imaging (abdo US, MRCP etc) which clearly delineates bile duct diameter and suggests non complex biliary stone disease.
4. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

1. Age \<18
2. Potentially vulnerable subjects including, homeless people, pregnant females, employees and students.
3. Participation in another related investigational study that could affect the results of this study within the previous 30 days
4. Complex biliary stone disease cases with unusual location of the stones (intra hepatic, cystic duct, stone proximal to bile duct stricture)
5. Known bile duct infection (cholangitis defined as ongoing fevers on the day of the ERCP procedure or purulence evident at the ampulla or bile duct on cannulation/sphincterotomy. If clear bile is aspirated during the study procedure, we will proceed according to study procedures. If purulence is detected upon aspiration of bile during the procedure, patient will be excluded from the study and undergo standard radiation-based ERCP rather than cholangioscopy.)

5) Complex post-surgical anatomy e.g. Billroth type II anatomy, Roux-en-Y-gastrojejunostomy

Primary outcomes:
measure: Stone clearance
timeFrame: During the cholangioscopy procedure
Secondary outcomes:
measure: Procedure Duration
timeFrame: 5 minutes to 2.5 hours anticipated time frame
Other outcomes:
measure: Adverse Events
timeFrame: up to 30 weeks post-procedure
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
citation: Barakat MT, Girotra M, Choudhary A, Huang RJ, Sethi S, Banerjee S. A prospective evaluation of radiation-free direct solitary cholangioscopy for the management of choledocholithiasis. Gastrointest Endosc. 2018 Feb;87(2):584-589.e1. doi: 10.1016/j.gie.2017.07.042. Epub 2017 Aug 7.
Clinical trial NCT02206867: Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
Official title: A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 116
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.


Eligibility criteria: Inclusion Criteria:

1. 20-45 years old healthy males
2. Body mass index 19.0 \~ 28.0 kg/m2

Exclusion Criteria:

1. Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
2. Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
3. Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
4. Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
5. Fever greater than 38.3℃ within a week prior to administration of study drug
6. Previous or current drug abuse

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity
timeFrame: 0 to 65 days
measure: Maximum measured concentration of the analyte in serum
timeFrame: 0 to 65 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital
name: Kyung-Sang Yu, M.D., Ph.D., M.B.A
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04637867: COVID-19 - Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study (NOSO-COR IMMUNO)
Official title: Multicentre Study on Nosocomial Transmission of SARS-CoV-2 Virus: an Ancillary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Viral
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: There are still uncertainties about the existence of protective immunity and the duration of protective antibodies in patients infected with SARS-CoV-2. Serological testing is an appropriate tool for epidemiological investigations to assess the persistence of antibodies over time. The nature of the immune response induced by this virus is also poorly understood. This ancillary study aims at assessing the immunological characteristics of patients that participated in the NOSO-COR study at Hospices Civils de Lyon six and twelve months after the initial infectious episode.

Two visits will be scheduled at 6 and 12 months (± 1 month) after the initial SARS-CoV-2 infectious episode, Blood, saliva and nasopharyngeal samples will be collected for seroprevalence and immunological investigation.


Eligibility criteria: Inclusion Criteria:

SARS-CoV-2 confirmed by RT-PCR

* Adults \> 18 years
* Signed consent form
* Affiliated to the French health system

Exclusion Criteria:

* Pregnant women
* Hospitalized patients
* Individuals subject to legal protection
* Imprisoned individuals
* Individuals who have expressed an opposition to participate, or who do not wish to donate blood samples

Primary outcomes:
measure: Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
timeFrame: Month 6
measure: Seroprevalence of SARS-CoV-2 antibodies in laboratory confirmed SARS-CoV-2 patients
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service épidémiologie, Hopital édouard Herriot
state: Rhone
city: Lyon
country: France
facility: hopital Edouard Herriot
Study officials:
affiliation: Lyon, France, 69003
name: Philippe VANHEMS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04654767: Inflammatory Profiling in Chronic Lung Disease
Official title: Inflammatory Profiling in Chronic Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Keywords: Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lead sponsor: Ludwig Boltzmann Institute for Lung Vascular Research
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
name: Medical University of Vienna
First posted: 2020-12-04
Enrollment: 60
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: Subjects undergoing lung transplantation at the Medical University of Vienna

Brief summary: The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.

Detailed description: Chronic lung diseases (CLD), such as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are often complicated by the presence of pulmonary hypertension (PH), where even a mild elevation of blood pressure in the pulmonary arteries is associated with an even poorer prognosis. In this study, we will investigate whether similarities exist in the inflammatory profile that could potentially underlie all forms of pulmonary hypertension. Inflammatory data will be generated using flow cytometry, expression profiling and histological analysis and compared to the associated clinical data.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lung transplant with COPD or IPF, with associated PH
* Signed informed consent

Exclusion Criteria:

* patients without written informed consent
* Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.

Primary outcomes:
measure: Analysis of inflammatory cell profile
timeFrame: within 36 months
Secondary outcomes:
measure: Degree of pulmonary vascular disease
timeFrame: within 36 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna
Study officials:
affiliation: Ludwig Boltzmann Institute for Lung Vascular Research
name: Leigh Marsh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03219567: Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care
Official title: Whole Eye Optical Coherence Tomography (OCT) to Improve Refractive Surgery and Eye Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Image, Body
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overall objective is to develop the hardware systems and software algorithms necessary to make accurate measurements of the whole eye with optical coherence tomography (OCT).

The research procedure that each subject will undergo is imaging with the OCT system. Three populations will be included: 1. Normals to ensure the imaging range of the system, 2. Patients with previous LASIK who will be undergoing cataract surgery, and 3. Patients with a history of cataract surgery or high myopia. The third group will also undergo MRI imaging for comparison.

There are no known risks to the subject from imaging with optical coherence tomography beyond what is normal for standard ocular photographic procedures. Light exposure is below ANSI limits. In groups 2 and 3, clinical parameters drawn from the OCT images will be compared to standard of care imaging.


Eligibility criteria: Inclusion Criteria:

* 21 years or older.
* Pseudophakic group: has had prior uncomplicated cataract surgery with a monofocal or toric intraocular lens, able to undergo head MRI
* High myopia group: refraction equal to or stronger than -6 D spherical equivalent, able to undergo head MRI

Exclusion Criteria:

* under 21 years of age, unable or unwilling to give consent.
* Pseudophakic group: complications with cataract surgery or insertion of a multifocal intraocular lens, failure to pass MRI pre-screening (e.g. prior metallic implants, claustrophobic), unable to fixate.
* High myopia group: failure to pass MRI pre-screening, unable to fixate.

Primary outcomes:
measure: Difference in Radius of Curvature (Rc) of the Posterior Eye From OCT Compared to MRI
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Duke Eye Center
state: North Carolina
Study officials:
References:
Clinical trial NCT01642667: Pharmacoinvasive Therapy With Prourokinase
Official title: The Efficacy and Safety of Pharmacoinvasive Therapy With Prourokinase for Acute ST Segment Elevation Myocardial Infarction Patients With Expected Percutaneous Coronary Intervention Related Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Lead sponsor: Suzhou Landing Pharmaceuticals
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 197
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to elucidate the efficacy and safety of pharmacoinvasive therapy by using prourokinase (prouk), a unique fibrin-specific agent, in patients with ST-segment elevation myocardial infarction (STEMI)


Eligibility criteria: Inclusion Criteria:

* age 75 years or younger, symptom onset 6 h or less before randomization, intention to undertake primary PCI, ST-segment elevation of 2 mm or more in two anterior leads or of 1 mm or more in two inferior leads if they had ST-segment elevation, or new left bundle-branch block.

Exclusion Criteria:

* expected arrival at the catheterization laboratory less than 1 h or more than 3 h after randomization, anticipated problems with vascular access, previous enrollment to other studies, and the usual contraindications to thrombolytic therapy.

Primary outcomes:
measure: angiographic parameters which can demonstrate the myocardium reperfusion, including TIMI flow grade (grade I-III), TIMI frame count (frame) and myocardial blush grade (MBG,grade 0-3).
timeFrame: 90 minutes after prourokinase bolus
Secondary outcomes:
measure: major adverse cardiac events [MACE, defined as the composite of all cause-death, reinfarction, revascularization (including target vessel and non-target vessel revascularizations), or rehospitalization due to new or worsening congestive heart failure]
timeFrame: 12 month after enrollment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenyang Northern Hospital
state: Liaoning
Study officials:
References:
citation: Han YL, Liu JN, Jing QM, Ma YY, Jiang TM, Pu K, Zhao RP, Zhao X, Liu HW, Xu K, Wang G, Wang B, Sun RH, Wang J. The efficacy and safety of pharmacoinvasive therapy with prourokinase for acute ST-segment elevation myocardial infarction patients with expected long percutaneous coronary intervention-related delay. Cardiovasc Ther. 2013 Oct;31(5):285-90. doi: 10.1111/1755-5922.12020.
Clinical trial NCT04451967: Acute Myocardial Infarction Study in Northeastern China
Official title: the Acute Myocardial Infarction Study in Northeastern China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: Yanbian University Hospital
name: Dunhua City Hospital in Jilin Province
name: Liaoyuan City Central Hospital
name: Dongliao People's Hospital
name: Songyuan Central Hospital
name: Changling People's Hospital
name: Siping Central People's Hospital
name: The First People's Hospital of Manchu Autonomous County
name: Changchun Center Hospital
name: Nongan People's Hospital
name: Beihua University
name: Jilin Hospital of Integrated Traditional Chinese and Western Medicine
name: Panshi City Hospital
name: Tonghua Central Hospital
name: Baishan Central Hospital
name: Jingyu People's Hospital
name: Meihekou Central Hospital
name: Baicheng Central Hospital
name: Tongyu First Hospital
First posted: 2020-06-30
Enrollment: 3159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients must be admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, including ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI). Final inclusion criteria must meet Fourth Universal Definition for Myocardial Infarction (2018)

Brief summary: This is a real-world prospective cohort study aiming to generate knowledge about the characteristics, treatments, and outcomes of hospitalized AMI patients in Jilin Province. The study includes hospitalizations diagnosed of AMI, including ST segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI).


Eligibility criteria: Inclusion Criteria:

* patients admitted within 7 days of acute myocardial ischemic symptoms with a primary clinical diagnosis of AMI, meet Fourth Universal Definition for Myocardial Infarction (2018)

Exclusion Criteria:

* Types 4a and type 5 AMI

Primary outcomes:
measure: all-cause death
timeFrame: 2 years post discharge
Secondary outcomes:
measure: major adverse cardiac events (MACE)
timeFrame: 2 years post discharge
Other outcomes:
Locations:
city: Changchun
country: China
facility: The second hospital of Jilin university
state: Jilin
Study officials:
affiliation: Second Hospital of Jilin University
name: Bin Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li T, Wu J, Liu J, Sun W, Qi C, Liu B, Wells GA, Wang J; Acute Myocardial Infarction Study in Northeastern China (AMINoC). Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study. BMJ Open. 2021 May 25;11(5):e042936. doi: 10.1136/bmjopen-2020-042936.