louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00498446: Magnetic Resonance Imaging of Atrial Septal Defects
Official title: Imaging of Atrial Septal Defects by Velocity Encoded Cardiovascular Magnetic Resonance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Septal Defect
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.

Detailed description: Background: Atrial septal defect (ASD) flow can be measured indirectly by velocity-encoded cardiovascular magnetic resonance (veCMR) of the pulmonary artery and aorta (Qp/Qs). Imaging the secundum ASD en face could potentially enable direct flow measurement and, additionally, provide valuable information regarding ASD size, shape, location, and proximity to other structures.

Methods: Patients referred for possible transcatheter ASD closure underwent a comprehensive standard evaluation including transesophageal and/or intracardiac echocardiography (ICE), and invasive oximetry. CMR was performed in parallel and included direct en face veCMR after an optimal double-oblique imaging plane was determined accounting for ASD flow direction and cardiac-cycle interatrial septal motion.

We hypothesized that En face veCMR using an optimized imaging plane can accurately determine ASD flow, size, and morphology, and that it would provide information incremental to comprehensive standard evaluation.

Eligibility criteria: Inclusion Criteria:

* Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure

Exclusion Criteria:

* Contraindications to magnetic resonance imaging
* known sinus venosus or primum defects

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cardiovascular Magnetic Resonance Center
state: North Carolina
Study officials:
affiliation: Duke Cardiovascular Magnetic Resonance Center
name: Raymond J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomson LE, Crowley AL, Heitner JF, Cawley PJ, Weinsaft JW, Kim HW, Parker M, Judd RM, Harrison JK, Kim RJ. Direct en face imaging of secundum atrial septal defects by velocity-encoded cardiovascular magnetic resonance in patients evaluated for possible transcatheter closure. Circ Cardiovasc Imaging. 2008 Jul;1(1):31-40. doi: 10.1161/CIRCIMAGING.108.769786.
Clinical trial NCT01274546: Long Term Foundation Knee Study
Official title: A Long-term, Multicenter Follow Up Study of the Cruciate-retaining Foundation Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include only subjects who received the cruciate-retaining Foundation Knee System during or before the year 2000 and who voluntarily consent to take part in this study.

Brief summary: The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the cruciate-retaining Foundation Knee system during or prior to the year 2000.


Eligibility criteria: Inclusion Criteria:

* Subject must have received a cruciate-retaining Foundation Knee system during or prior to the year 2000.
* Surgery must have been a primary knee replacement.
* Subject must have received only one primary knee replacement per hospitalization
* Subject must have had a primary diagnosis of osteoarthritis of the operative knee.
* Subject is able and willing to sign the informed consent document

Exclusion Criteria:

* Subject must not have had any previous knee implants (unicondylar or total joint replacements)
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner

Primary outcomes:
measure: Survivorship of the Device
timeFrame: Single visit
Secondary outcomes:
measure: Knee Society Score Evaluation
timeFrame: Single visit
measure: Short Form - 36
timeFrame: Single Visit
measure: Oxford Knee Score Assessment
timeFrame: Single visit
measure: WOMAC Osteoarthritis Index
timeFrame: Single visit
measure: Range of Motion
timeFrame: Single visit
measure: Radiographic failure
timeFrame: Single visit
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Charleston
country: United States
facility: Charleston Orthopaedic Assoc.
state: South Carolina
Study officials:
affiliation: Charleston Orthopedic Association
name: Richard J Friedman, M.D.
role: PRINCIPAL_INVESTIGATOR
name: Joseph A Longo III, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756546: Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis
Official title: Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Systemic Lupus Erythematosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in plasma of SLE patients and difference in their expression among groups with different systemic lupus erythematosis disease activity index (SLEDAI) scores.


Eligibility criteria: Inclusion Criteria:

* Adult systemic lupus erythematosis patients

Exclusion Criteria:

* Patients younger than 18 years, patients with other autoimmune diseases or malignancy.

Primary outcomes:
measure: MicroRNAs expression level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05786846: Serum Thyroid Function After Iodinated Contrast Administration
Official title: Serum Thyroid Function After Iodinated Contrast Administration in Chinese Euthyroid Adults: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Dysfunction
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are identified of having undergone a radiological examination use of an iodinated contrast agent in Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Brief summary: This study investigated the changes in serum thyroid function and urinary iodine levels before and after the use of iodinated contrast to analyze the prevalence of thyroid dysfunction in the Chinese euthyroid adults after using iodinated contrast.

Detailed description: This study aims to monitor the thyroid function, urinary iodine level, and other indicators of patients after using iodine contrast agents, in order to analyze the prevalence of thyroid dysfunction after using iodine containing contrast agents, and investigate the impact of different iodine contrast agents on thyroid function, in order to provide evidence for the use of iodine contrast agents in clinical practice and the risk prevention of subsequent thyroid diseases.

Eligibility criteria: Inclusion Criteria:

* patients who use iodinated contrast agent

Exclusion Criteria:

* patients with the following diseases: malignant tumor, critical illness (admitted to ICU), mental disease, hypothalamus-pituitary disease.
* administration of anti-thyroid drugs (methimazole, propylthiouracil), levothyroxine, compound iodine solution, amiodarone, immunostaining point inhibitor, tyrosine kinase inhibitor, interferon, interleukin-6, lithium, glucocorticoids β Receptor blockers, dopamine, dobutamine, bromocriptine, octreotide, phenobarbital, phenytoin sodium, rifampicin, and carbamazepine within the past 6 months

Primary outcomes:
measure: Incidence rate of thyroid dysfunction after administration of iodine contrast agent.
timeFrame: up to 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Li Yan
role: STUDY_DIRECTOR
References:
Clinical trial NCT04991246: Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
Official title: Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Simulation
epidemiology
public health
computer science
infectiology
technology
pandemic COVID
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The worldwide health system has been marked by the SARS-CoV-2 pandemic. French educational system has been upset, especially medical schools, which, because of their hospital location, are particularly exposed to the spread of the virus. The medical school of Paris-Saclay University, located within bicetre University Hospital, AP-HP, must therefore adapt on a daily basis to ensure educational continuity. Taking advantage of an exceptional scientific ecosystem, innovative viral epidemic propagation modeling approaches based on both simulation and contact tracing data will be tested in real-life conditions. These propagation models will serve to scientifically optimize future educational organization procedures in this medical school.

Detailed description: All the participants will be equipped with individual wireless contact tracing technology. Anonymised contact events will be automatically monitored for a period of two months to measure the daily contact flow density between the students at medical school. Epidemic simulation models will be enriched with these real contact tracing data to generate optimized viral propagation probability networks. During the same period, CO2 measurement will be performed in several relevant sectors (classrooms, amphitheaters, corridors etc) to allow a more holistic understanding of the propagation conditions. Finally, the probabilistic models will be confronted to the results of a two step COVID-19 screening campaign.

Eligibility criteria: Inclusion Criteria:

* Volunteers of adult men and women over 18 from the Paris-Saclay Medicine UFR

  * Belonging to the teaching staff
  * Belonging to the promotions of DFGSM 2 and 3, and DFASM 1 and 2 (2nd to 5th year of medical study)
  * administrative staff
* Affiliated to a social security scheme or beneficiary (excluding AME)
* Informed and written consent

Exclusion Criteria:

* Absence of intercurrent disease before inclusion
* Positive antigenic or PCR test at the time of inclusion

Primary outcomes:
measure: Simulations results compared with the COVID-19 two-step screening campaign results
timeFrame: 2 months
Secondary outcomes:
measure: CO2 atmospheric measurement
timeFrame: 2 months
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
Study officials:
affiliation: Bicetre Hospital
name: Olivier LAMBOTTE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00218946: Nasogastric Tube in Premature Babies - Pain and Treatment
Official title: Nasogastric Tube in Premature Babies - Pain and Treatment. A Randomised, Partly Blinded, Placebo-controlled Factorial Clinical Trial of Sucrose and Pacifier
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant, Premature
Keywords: pain
infant, premature
intubation, gastrointestinal
Neonatal nursing
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

Detailed description: A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.

Eligibility criteria: Inclusion Criteria:

* 28 - 32 weeks gestational weeks
* not on mechanical ventilation

Exclusion Criteria:

* high risk group regarding cerebral prognosis

Primary outcomes:
measure: Pain measured on PIPP (Premature Infant Pain Profile) scale
timeFrame: 4 week to complete
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Eirik Skogvoll, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
citation: Kristoffersen L, Skogvoll E, Hafstrom M. Pain reduction on insertion of a feeding tube in preterm infants: a randomized controlled trial. Pediatrics. 2011 Jun;127(6):e1449-54. doi: 10.1542/peds.2010-3438. Epub 2011 May 2.
Clinical trial NCT02902146: Bougie Use in Emergency Airway Management
Official title: Bougie Use in Emergency Airway Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 757
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 prospective, open-label trial randomizes adult patients intubated in the ED with a Macintosh blade to use or not use a bougie for the first intubation attempt. The primary outcome is first pass success.

Detailed description: The primary analysis for all outcomes will be for those with a difficult airway characteristic (defined as any of: cervical immobility, obesity, large tongue, short neck, small mandible, facial or neck trauma, airway edema, blood in the airway, or vomit in the airway).

We will also analyze all outcomes for all patients enrolled, regardless of whether they have a difficult airway characteristic.

We plan to enroll 374 patients with a difficult airway characteristic (DAC). The total enrollment for the trial will be higher, depending on the proportion of patients that have a DAC.

Based on observational data, we aim to detect a 9% absolute difference in first pass success (95% with bougie compared to 86% without the bougie), which requires enrollment of 374 patients with a DAC.

To help achieve balanced randomization for patients with a DAC, patients are stratified into two groups: 1) obese or cervical immobilization present and 2) not obese and no cervical immobilization.

Eligibility criteria: Inclusion Criteria:

1. The patient must be undergoing orotracheal intubation in the ED with a Macintosh blade (using either video or direct laryngoscopy)
2. The patient must be presumed to be 18 years of age or older at the time of enrollment.

Exclusion Criteria:

1. Known anatomic distortion of the upper airway or perilaryngeal structures.
2. Prisoner or under arrest
3. Known or suspected to be pregnant, based on the opinion of the treating physician.

Primary outcomes:
measure: Number of Participants With First Pass Success
timeFrame: 5 minutes
Secondary outcomes:
measure: First Pass Success Without Hypoxemia
timeFrame: 5 minutes
measure: Time to Intubation (First Attempt)
timeFrame: 5 minutes
measure: Esophageal Intubation
timeFrame: 5 minutes
measure: Hypoxemia
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
citation: Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
Clinical trial NCT06270446: Community Based Rehabilitation Model After Total Knee Replacement
Official title: Community Based Rehabilitation Model After Total Knee Replacement: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 59
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Detailed description: To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Eligibility criteria: Inclusion Criteria:

i) unilateral TKA; ii) age 55 years old and above; iii) able to engage in outpatient physiotherapy; iii) postoperative knee flexion ≥75° and knee extension ≤5°; iv) able to ambulate independently preoperatively.

Exclusion Criteria:

i) had revision TKA or fully constrained knee arthroplasty; ii) had knee replacement for indications other than osteoarthritis; iii) had post-operative complications during hospital stay; iv) were unable to participate due to cognitive impairment or language barriers; v) had acute spinal diseases or joint, muscle or systemic diseases affecting gait; iv) had comorbid health conditions that would prevent active participation (e.g. prior hemiplegic stroke, severe cardiorespiratory illnesses.

Primary outcomes:
measure: TUG
timeFrame: 3 months
measure: 30 sec chair stand test
timeFrame: 3 months
measure: Pain intensity
timeFrame: 3 months
Secondary outcomes:
measure: Knee flexion and extension
timeFrame: 3 months
measure: Passive range of motion
timeFrame: 3 months
measure: Presence of lag
timeFrame: 3 months
Other outcomes:
measure: OKS
timeFrame: 3 months
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Eng Chuan Neoh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347646: A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Official title: An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Vitreoretinal Traction Syndrome
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Plasmin is expected to create a posterior vitreous detachment (PVD) when injected directly into the eye. The pharmacological creation of a PVD may be beneficial in helping to treat a variety of conditions.


Eligibility criteria: Inclusion Criteria:

* Patients who are in need of a vitrectomy.

Exclusion Criteria:

* A PVD in the study eye as assessed by the investigator using ophthalmic and alternative examination techniques.
* A history of vitrectomy in the study eye.
* A media opacity that precludes quality examination of the vitreous and fundus in the study eye.

Primary outcomes:
measure: Presence of a Posterior Vitreous Detachment (PVD)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
References:
Clinical trial NCT04784910: Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peptic Ulcer
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 423
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.


Eligibility criteria: Inclusion Criteria:

1. Male and female adults aged ≥ 19 years at the time of informed consent
2. Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
3. Subjects with at least one of the following risk factors for ulcer development at screening.
4. Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.

Exclusion Criteria:

1. Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
2. Subjects who have undergone gastroduodenal surgery or total small bowel resection
3. Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
4. Subjects who have had a malignant tumor in the last 5 years
5. Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs

Primary outcomes:
measure: Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
timeFrame: at 24 weeks
Secondary outcomes:
measure: Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator
timeFrame: at 12 weeks
measure: Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24
timeFrame: at 12, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: