louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02799992: Pseudo-PDT in Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Central Serous Chorioretinopathy
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 22
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: Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients, characterized by serous retinal detachment in the macular region. We evaluated half-dose verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805 mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography findings were compared between groups.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years;
* patients with best-corrected visual acuity (BCVA) of 20/200 or better;
* presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment involving the fovea on optical coherence tomography (OCT);
* presence of active angiographic leakage in fluorescein angiography caused by CSC and no other diseases, and abnormal dilated choroidal vasculature and other features in indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

Exclusion Criteria:

* any previous treatment for CSC;
* evidence of choroidal neovascularization or other maculopathy on fundus examination.

Primary outcomes:
measure: Best-corrected Visual Acuity (LogMAR)
timeFrame: 6 months
measure: Central Retinal Thickness (micron)
timeFrame: 6 months
measure: Subfoveal Choroidal Thickness (micron)
timeFrame: 6 months
Secondary outcomes:
measure: Ellipsoid Zone Recovery (integrity of IS/OS line)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02606292: Photoacoustic Endoscopy of Barrett's Esophagus
Official title: Photoacoustic Endoscopy of Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Barrett Esophagus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 8
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: Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues.

The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older.
* Patients with Barrett's esophagus scheduled for esophageal surgery.
* Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
* Subjects must be able to understand and willing to sign a written informed consent form.

Exclusion Criteria:

* Inability to give informed consent.
* Pregnancy.
* Age less than 18 years
* Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
* Acute GI bleeding.
* Coagulopathy.

Primary outcomes:
measure: Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium
timeFrame: Day 1
measure: Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Bryan F Meyers, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898492: Quality Assessment of a Training Period for Physical and Mentally Disabled People
Official title: Quality Assessment of a Training Period for Physical and Mentally Disabled People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disabled Persons
Exercise
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2019-04-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One intervention group and one control group
Primary purpose: PREVENTION

Brief summary: The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.

Detailed description: This study aimed at making a quality assessment of a 8 week training period for adults with physical and mental disabilities. A control group was added to compare the effect of the training with no training. Before the training period the participants were tested in relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair stand test and waist circumference. In addition to this, the participants were instructed to wear an accelerometer to measure step and active minutes for 2-3 days a work.

The staff at the day center, where the participants works in daytime, were responsible for the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic, strength, balance and flexibility training.

The participants were tested after the training period using the same test-protocol as before.

Eligibility criteria: Inclusion Criteria:

* User of the centers included in the study
* Being able to stand alone
* Being able to use an exercise bike
* Being able to understand danish

Exclusion Criteria:

* Pregnancy
* Pacemaker
* Not being able to stand up by themselves

Primary outcomes:
measure: Body mass index
timeFrame: Through study completion, an average of 8 weeks
measure: Blood pressure
timeFrame: Through study completion, an average of 8 weeks
measure: Completed chair stands
timeFrame: Through study completion, an average of 8 weeks
measure: Aastrand test
timeFrame: Through study completion, an average of 8 weeks
measure: Waist circumference
timeFrame: Through study completion, an average of 8 weeks
measure: Physical activity
timeFrame: During test session - 2-3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Physiotherapy, University College of Northern Jutland
Study officials:
affiliation: University College of Northern Jutland, Denmark. Department of Physiotherapy
name: Dorte Drachmann, Msc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00847392: Study to Determine Pediatric Bladder Volume Prior to Catheterization
Official title: Pediatric Volumetric Bladder Ultrasound Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Urethral catheterization
Emergency Department
Ultrasound
Urinary tract infection
Pediatric
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 0
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.

Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.


Eligibility criteria: Inclusion Criteria:

* Children 0-36 months of age
* Require urethral catheterization for urine analysis

Exclusion Criteria:

* Recently voided and unlikely to provide sufficient urine when catheterized
* Documented or suspected genitourinary abnormalities precluding urethral catheterization
* Indwelling catheter or urostomy
* Critical illness
* No available legal guardian or legal guardian does not understand English well enough to provide informed consent
* Technical failure of the utlrasound equipment

Primary outcomes:
measure: The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.
timeFrame: First feasible attempt at catheterization during ED visit (minutes-hours).
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Andrew Worster, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00396292: Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Official title: Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Anemia
postpartum
Postpartum anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 361
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.

Detailed description: This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.

Eligibility criteria: Inclusion Criteria:

* Female Subjects able to give consent
* Post partum patients
* Baseline Hbg\< /= 10
* Agree to practice birth control
* Demonstrate willingness to comply with protocol restrictions

Exclusion Criteria:

* Known hypersensitivity reaction to oral or IV iron (VIT-45)
* Documented history of discontinuing oral iron
* Significant bleeding
* History of anemia other that iron deficiency anemia
* Severe Psychiatric disorders
* Active severe infection
* Known Hepatitis B antigen or Hep C viral antibody or active hepatitis
* Known HIV antibody
* Received investigational product within 30 days
* Alcohol abuse
* Hemochromatosis or other iron storage disorder

Primary outcomes:
measure: Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin
timeFrame: anytime between baseline and the end of study or time to intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References:
citation: Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
citation: Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.
citation: Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.
Clinical trial NCT00518492: Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Official title: Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Upon completion of participation in the 6108A1-500 study, subjects will be asked to consent for this duration of immunity study to provide up to two additional blood samples. SBA \& IgG testing will be done on these samples taken at 6 \& 12 months. The sites participating in this duration of immunity study are the same sites participating in the 6108A1-500 study.


Eligibility criteria: Inclusion Criteria:

* Completed study 6108A1-500 (three doses administered and visit 9 completed).

Exclusion Criteria:

* Bleeding diathesis or condition associated with prolonged bleeding time.
* Any clinically significant chronic disease that, in the investigators judgment may be worsened by blood draw.

Primary outcomes:
measure: Immunogenicity at 6 and 12 months post 6108A1-500 study.
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Herson
country: Australia
state: Queensland
city: North Adealaide
country: Australia
state: South Australia
city: Perth
country: Australia
state: Western Australia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia: medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605692: Evaluation of Occupational Burnout and Stress Among Dentists in Covid-19 Pandemic
Official title: Attitudes and Predictive Factors of Psychological Distress and Occupational Burnout Among Dentists During COVID-19 Pandemic in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout
COVID-19
Dentistry
Filiation
Pandemic
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 706
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants included dentists dealing with COVID-19 patients vs. those who are not dealing with COVID-19 patients from hospitals and health centers inside Turkey, totaly 706.

Our questionnaires were used to assess their mental health by measuring burnout and stress levels. Participants' socio-demographic data such as age, gender, profession, marital state, years of experience, weekly working hours were collected.

Brief summary: The aim of this study was to evaluate the factors affecting the ability and willingness of dentists to work during the COVID-19 pandemic and the effect of this situation on occupational burnout. A 51-question survey, including demographic and pandemic questions and the Maslach Burnout Inventory (MBI), was used as a data collection method and administered to dentists in Turkey via the internet in two stages. A link to the survey (onlineanketler.com) was sent to the participants by e-mail or social media (WhatsApp©). A total of 706 participants were included in the study. The second stage of the survey only applied to dentists who are assigned within the scope of COVID-19 measures in Turkey.


Eligibility criteria: Inclusion Criteria:

* All dentist working during the COVID-19 outbreak
* Accepted electronically to participate in our study
* Completed and submitted our electronic questionnaires successfully

Exclusion Criteria:

* Non-dentists
* Did not accept electronically to participate in our study
* Did not complete not submitted our electronic questionnaires successfully

Primary outcomes:
measure: 706 of participants' burnout (MBI) and stress levels during the Covid 19 pandemic process assessed with survey.
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz Üniversitesi
state: Konyaaltı
Study officials:
References:
citation: Ozarslan M, Caliskan S. Attitudes and predictive factors of psychological distress and occupational burnout among dentists during COVID-19 pandemic in Turkey. Curr Psychol. 2021;40(7):3113-3124. doi: 10.1007/s12144-021-01764-x. Epub 2021 Apr 29.
Clinical trial NCT03712189: LifeFlow Fluid Study- Non- Critical Pediatric Patients Having a Trans Abdominal Ultrasound
Official title: The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration in Children
Dehydration
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: 410 Medical
name: Atlanta Pediatric Device Consortium
First posted: 2018-10-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.

Detailed description: Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.

Eligibility criteria: Inclusion Criteria:

* Female patients older than 1 month and less than 18 years
* Patients require IV crystalloid bolus fluids before a pelvic ultrasound

Exclusion Criteria:

* Known cardiac insufficiency or significant cardiac surgery
* Hepatic insufficiency
* Renal insufficiency
* Any known fluid overload states (ascites, pulmonary edema)
* On any diuretic or antihypertensive therapy
* Known pregnancy

Primary outcomes:
measure: Duration- Ultrasound Ordered to Completed
timeFrame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
Secondary outcomes:
measure: Total IV Fluid (mL)
timeFrame: From ED arrival to discharge/admission, less than 12 hours
measure: Duration- Full Bladder
timeFrame: From ED arrival to discharge/admission, less than 12 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Todd P Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Los Angeles
name: Ara Festekjian, MD
role: STUDY_DIRECTOR
References:
citation: Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583.
Clinical trial NCT00605189: A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
Official title: A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.


Eligibility criteria: Inclusion Criteria:

* Type II diabetes
* Subject has a diabetic foot ulcer 5cm squared or greater
* Subject's diabetic foot ulcer is chronic

Exclusion Criteria:

* HgbA1c of 12% or greater
* Presence of cellulitis
* Presence of osteomyelitis

Primary outcomes:
measure: Compare Energy Charge Between Wound Treatment Therapies
timeFrame: Day 0, Day 2, Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: Ohio State University
name: Gayle M Gordillo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01368692: Effect of Shoulder Retraction on Success Rate of Subclavian Vein Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subclavian Vein Catheterization
Keywords: subclavian vein catheterization success rate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-06-08
Enrollment: 362
Sex: ALL
Minimum age (years): 16
Maximum age (years): 82
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the shoulder retraction by placing a saline bag between the scapula influences a success rate of subclavian vein catheterization.


Eligibility criteria: Inclusion Criteria:

* adult patients undergoing neurosurgery or thoracic surgery that requires the placement of subclavian venous catheterization

Exclusion Criteria:

* infection over the puncture site
* history of prior clavicular fracture
* anatomical anomaly of subclavian vein

Primary outcomes:
measure: catheterization success rate
timeFrame: immediately after catheterization (an expected average of 1 hour)
Secondary outcomes:
measure: location of catheter tip
timeFrame: an expected average of one day after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim HJ, Jung SH, Min J, Hong DM, Jeon Y, Bahk JH. Comparison of the neutral and retracted shoulder positions for infraclavicular subclavian venous catheterization: a randomized, non-inferiority trial. Br J Anaesth. 2013 Aug;111(2):191-6. doi: 10.1093/bja/aet026. Epub 2013 Mar 10.