louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06539715: Comparison of Visual Field Assessments Between Three Perimeters
Official title: Comparison of Visual Field Assessments Between Three Perimeters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Gainesville Eye Associates
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2024-08-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.


Eligibility criteria: Inclusion Criteria:

* Adult patients with best-corrected visual outcomes of 20/30 or better.

Exclusion Criteria:

* Unable to tolerate ophthalmic imaging
* Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Primary outcomes:
measure: Total acquisition time (both eyes)
timeFrame: Visit 1 (Day 0)
Secondary outcomes:
measure: Mean deviation (MD)
timeFrame: Visit 1 (Day 0)
measure: Pattern standard deviation (PSD)
timeFrame: Visit 1 (Day 0)
measure: Foveal threshold (FT)
timeFrame: Visit 1 (Day 0)
measure: Patient questionnaire
timeFrame: Visit 1 (Day 0)
Other outcomes:
measure: Visual field index (VFI)
timeFrame: Visit 1 (Day 0)
measure: Setup time
timeFrame: Visit 1 (Day 0)
measure: False positives and false negatives (frequency)
timeFrame: Visit 1 (Day 0)
Locations:
city: Gainesville
country: United States
facility: North Georgia Eye Associates
state: Georgia
Study officials:
affiliation: North Georgia Eye Associates
name: Clayton Blehm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03443115: Duchenne Muscular Dystrophy Heart Study
Official title: Multicenter Cohort Study on Duchenne Muscular Dystrophy Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy-Associated Dilated Cardiomyopathy
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
Collaborators: name: Association Monégasque contre les Myopathies
First posted: 2018-02-22
Enrollment: 700
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients diagnosed with Duchenne muscular dystrophy and referred to reference centers for neuromuscular diseases for the management of their condiction.

Brief summary: Retrospective cohort study including patients with genetically proven Duchenne muscular dystrophy, diagnosed from January 1993 to March 2020.

Inclusion of the data relative to genetic diagnosis, clinical characteristics at baseline, cardiac and respiratory workup, medical treatments (ACE inhibitors, steroids), surgical procedures, and occurrence during follow-up of cardiac, respiratory and fatal events.

Objectives are to describe long-term natural history of the disease, vital prognosis, genotype-phenotype correlations, effect of treatments.


Eligibility criteria: Inclusion Criteria:

* Genetically-proven Duchenne Muscular Dystrophy (DMD mutation)
* Covering by social security

Exclusion Criteria:

* Patient refusal to participate to the study

Primary outcomes:
measure: All-cause mortality
timeFrame: Follow-up completed in March 2020
Secondary outcomes:
measure: Hospitalization for heart failure
timeFrame: Follow-up completed in March 2020
measure: Dilated cardiomyopathy
timeFrame: Follow-up completed in March 2020
measure: Hospitalization for acute respiratory failure
timeFrame: Follow-up completed in March 2020
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Reference Center for Neuromuscular Diseases
Study officials:
References:
citation: Porcher R, Desguerre I, Amthor H, Chabrol B, Audic F, Rivier F, Isapof A, Tiffreau V, Campana-Salort E, Leturcq F, Tuffery-Giraud S, Ben Yaou R, Annane D, Amedro P, Barnerias C, Becane HM, Behin A, Bonnet D, Bassez G, Cossee M, de La Villeon G, Delcourte C, Fayssoil A, Fontaine B, Godart F, Guillaumont S, Jaillette E, Laforet P, Leonard-Louis S, Lofaso F, Mayer M, Morales RJ, Meune C, Orlikowski D, Ovaert C, Prigent H, Saadi M, Sochala M, Tard C, Vaksmann G, Walther-Louvier U, Eymard B, Stojkovic T, Ravaud P, Duboc D, Wahbi K. Association between prophylactic angiotensin-converting enzyme inhibitors and overall survival in Duchenne muscular dystrophy-analysis of registry data. Eur Heart J. 2021 May 21;42(20):1976-1984. doi: 10.1093/eurheartj/ehab054.
Clinical trial NCT01634815: Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization
Official title: Evaluation of Local Capillary Blood Lactate in Chronic Critical Ischemia of Lower Limb Before and After Revascularization.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Critical Ischemia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-07-06
Enrollment: 12
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: Evaluation of a new biological criterion, the local capillary blood lactates to optimize the management of patients with chronic critical ischemia requiring revascularization fast. Potential use in terms of capillary blood lactate as a diagnostic indicator of recurrent ischemia in a limb revascularized.


Eligibility criteria: Inclusion Criteria:

* Ischemia Chronic critical lower limb revascularization procedure requiring fast.
* Written consent informed patient age greater than or equal to 18

Exclusion Criteria:

* Presence of an inflammatory or infectious (erysipelas) in the ischemic member.
* Patients at risk for diabetic foot ie, as defined by the HAS (preventing diabetic foot, 2007)

  * presence of sensory neuropathy, and / or
  * foot deformities (hallux valgus, hammer toes or claw, prominence of the metatarsal heads), and / or
  * history of foot ulceration, and / or
  * antecedent of one of these factors (ie antécedant diabetic foot).
* Necrosis of the toes.
* Participation in another clinical research protocol.
* Presence of peripheral arterial disease in the bilateral upper limbs.
* Patient in shock whatever the cause.
* Presence of hepatic failure.
* Too impaired general condition (bedridden, dementia, ...)
* Refusal of the patient to participate in the study
* Protected patients

Primary outcomes:
measure: Report Capillary blood lactate To Finger Capillary blood lactate (LCO / LCD)
timeFrame: 48 hours
Secondary outcomes:
measure: The decrease in the ratio LCO/LCD
timeFrame: 48 hours
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg, Service d' Anesthésie Réanimation Chirurgicale
Study officials:
affiliation: not affiliated
name: Pierre Diemunsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07015515: PAPE Effect With Blood Flow Restriction and Push-Up Exercise (Post-Activation Performance Enhancement)
Official title: Acute Effects of Push-Up Exercise Performed Under Varying Blood Flow Restriction Conditions on Upper Extremity Explosive Power Performance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Flow Restriction Exercise
Keywords: BFR
push-up exercise
PAPE
radar measurement
explosive power
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to compare the acute effects of push-up exercises performed under different blood flow restriction (BFR) conditions on upper extremity explosive strength performance, measured via the seated unilateral medicine ball throw test.

Detailed description: The study includes three push-up conditions (BFR, sham BFR, and no BFR). Performance is evaluated via medicine ball throws at the 4th, 8th, and 12th minutes post-exercise. Exercises are applied in a crossover design with 50% limb occlusion pressure (LOP) BFR, sham, and control arms. Throw distance and ball velocity (measured by radar device) are primary outcomes. RPE scale is used to assess perceived exertion.

Eligibility criteria: Inclusion Criteria:

* Being between 18 and 25 years old
* Being a volleyball player
* Having trained regularly in the last 6 months
* Ability to perform at least 5 repetitions of push-up with own body weight
* Voluntarily agreeing to participate and signing the informed consent form

Exclusion Criteria:

* History of shoulder or upper extremity injury requiring physical therapy or surgery
* History of venous thromboembolism
* Hematological disorders
* Coronary artery disease
* Peripheral arterial disease
* Hypertension (systolic/diastolic \> 140 mmHg/90 mmHg)
* History or high risk of deep vein thrombosis
* Blood clotting disorders
* Poor circulation
* Inadequate lymphatic system
* History of endothelial dysfunction
* Varicose veins
* Peripheral vascular disease
* Diabetes
* Easy bruising
* Active infection
* Cancer
* Renal failure
* Pregnancy
* Intolerance to intervention

Primary outcomes:
measure: throw distance
timeFrame: will be measured immediately after the exercise protocol is completed three times at 4th, 8th, and 12th minutes
Secondary outcomes:
measure: Ball velocity (km/h)
timeFrame: will be measured by radar device after completion of the exercise three times at 4th, 8th, and 12th minutes
measure: Rating of Perceived Exertion (RPE)
timeFrame: 1 day (will be assessed at the end of the push-up exercise)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
Study officials:
affiliation: Istanbul University
name: Şensu Dinçer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05702515: Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study
Official title: Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral ICC
Keywords: VPS
VPS G4
Vascular Positioning System G4
PICC navigation and tip confirmation
Lead sponsor: Teleflex
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2023-01-27
Enrollment: 27
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male patients scheduled to receive a PICC insertion using the G4 tip navigation system may be considered for participation in the study.

Brief summary: The objective of this study is to collect intravascular and extravascular echocardiogram (ECG) data from subjects receiving peripherally inserted central catheters (PICC) while using the Vascular Positioning System G4 and a 12 lead ECG machine. The data obtained will be used to update the G4 algorithm.

Detailed description: This study seeks to collect synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure. A copy of the data will be downloaded from the G4 and ECG machines and submitted to the sponsor. Both the G4 and the ECG machine used for data collection in this study are FDA cleared/approved.

Study Design: This is a single center prospective clinical study. All enrolled subjects will receive a 12-lead ECG during PICC insertion and a chest x-ray post insertion. ECG lead will be documented via photographic imaging.

Duration of Subject Study Participation: Each subject's participation will start at the time of signing the informed consent and terminate upon completion of the x-ray.

Eligibility criteria: Inclusion Criteria:

* Male

  * 21 years of age or older
  * Scheduled for PICC insertion using the VPS G4 system
  * Willing to allow thoracic photos to be obtained after ECG lead placement

Exclusion Criteria:

* Female

  * ˂ 21 years of age
  * Patient has a pacemaker
  * Patient condition precluding ECG use and lead placement
  * Patient condition precluding radiographic imaging
  * Unwilling to allow thoracic photos to be obtained after ECG lead placement

Primary outcomes:
measure: VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data
timeFrame: From time of consent through completion of chest x-ray
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Teleflex Inc
name: Tatiana Puga, B.S.B.
role: STUDY_DIRECTOR
affiliation: Duke University
name: Deborah H Allen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Britt M Meyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06941415: Bumetanide vs. Furosemide in Cirrhosis
Official title: Bumetanide vs. Furosemide for Adults Hospitalized With Cirrhosis: the BUFF Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cirrhosis
Keywords: cirrhosis
volume overload
diuresis
furosemide
bumetanide
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 500
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: Patients with cirrhosis are frequently hospitalized due to an acute decompensation of their liver disease including bleeding, jaundice, encephalopathy, and volume overload. Volume overload is associated with increased mortality from acute hypoxic respiratory failure, hemorrhage from esophageal varices, and spontaneous bacterial peritonitis.

Clinical practice guidelines describe sodium restriction and diuretics as first-line treatment, combined with regular body weight monitoring to assess response. In patients with suboptimal response to furosemide, alternative loop diuretics like torsemide or bumetanide may improve natriuresis. Bumetanide has a theoretic advantage over furosemide due to its more rapid and complete intestinal absorption, combined with a prolonged half-life in patients with hepatic dysfunction. In this pragmatic study, the aim is to compare the efficacy of diuresis with bumetanide versus furosemide among hospitalized patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* History of liver cirrhosis
* Clinician placed an order for bumetanide or furosemide in electronic health record within 24 hours of presentation to the hospital

Exclusion Criteria:

* Allergy to bumetanide or furosemide
* Contraindication to diuretic administration (e.g. active bleeding, clinical suspicion of hepatorenal syndrome, hypotension)
* Incarcerated or in custody of law enforcement
* Diuretic ordered for purpose other than volume overload (e.g. hyperkalemia, continuation of home medication without clinical signs of volume overload)
* Inpatient admission not anticipated
* Not admitted to an inpatient hospital bed following initial evaluation in the emergency department

Primary outcomes:
measure: Percent change in weight
timeFrame: 7 days
Secondary outcomes:
measure: Development of acute kidney injury
timeFrame: 14 days
measure: Need for replacement therapy
timeFrame: 14 days
measure: Severe electrolyte derangement
timeFrame: 14 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Unplanned hospital readmission
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Stacy A Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02161315: Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer
Official title: A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma Breast Stage IV
Keywords: SAID, Progestogens, nSAID-resistanced, LSBC
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80

Brief summary: Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.

Detailed description: A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility criteria: Inclusion Criteria:

1. Patients must be the postmenopausal women
2. Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology
3. Immunohistochemistry shows ER and/or PR positive
4. Patients ECOG score must be 0-2
5. Drug resistant about Non-Steroid Aromatase Inhibitors

Exclusion Criteria:

1. Not suitable for endocrine therapy
2. Have receive the standard Steroid Aromatase Inhibitors treatment
3. Severe hepatic dysfunction

Primary outcomes:
measure: RECIST 1.1
timeFrame: -7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Yehui Shi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01460615: Cortisone Treatment for the Prevention of Postoperative Pancreatitis and Pancreatitis-induced Complications After Pancreaticoduodenectomy and Distal Pancreatic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Complications
Postoperative Pancreatitis
Keywords: Postoperative pancreatitis
Postoperative complications
Delayed gastric emptying
Leakage
Fistula
Acinar cell
Risk patient
Pancreaticoduodenectomy
Whipple
Cortisone
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-10-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).


Eligibility criteria: Inclusion Criteria:

* Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital

Exclusion Criteria:

* Patients with an ongoing cortisone treatment
* Cefuroxime allergy
* Chronic pancreatitis

Primary outcomes:
measure: Postoperative overall complications of pancreatic resection
timeFrame: within the first 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
citation: Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.
Clinical trial NCT05402215: The Effect of the Flipped Classroom Model on Teaching Clinical Practice Skills
Official title: The Effect of the Flipped Classroom Model on Teaching Clinical Practice Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flipped Classroom Model in Teaching
Keywords: Flipped classroom model
Clinical Practice Skills
Nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: stratified randomization method
Primary purpose: BASIC_SCIENCE

Brief summary: This research is a randomized controlled experimental study planned to examine the effect of the flipped classroom model in teaching clinical practice skills. The research was carried out on first year students of the First and Emergency Aid Program at a state university in Turkey. The data were collected for one year, in the fall and spring terms. The universe of the research consisted of 46 students enrolled in the 2021-2022 Academic Year First and Emergency Aid Program and studying in the first year. In the study, stratified randomization method was used since it was thought that random selection could affect the study statistically in assigning students to groups. The data of the study were collected using the "Descriptive Characteristics Information Form", which includes the introductory information of the students, and the "Check List", which includes the clinical practice skill steps. While the flipped classroom model was used in teaching clinical practice skills of students in the experimental group, standard lectures were used in the control group.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old

Exclusion Criteria:

* who refused to participate in the study

Primary outcomes:
measure: Control List
timeFrame: immediately after application
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Üniversitesi
state: Talas
Study officials:
affiliation: Kayseri University
name: Ali KAPLAN, Dr.
role: PRINCIPAL_INVESTIGATOR
References: