louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05891106: AONDA Therapeutic Indication Study I
Official title: AONDA Therapeutic Indication Study I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Keratopathy
Corneal Erosion
Entropion
Corneal Edema
Corneal Dystrophy
Corneal Ulcer
Foreign Body in Cornea
Bell Palsy
Keratoconjunctivitis
Filamentary Keratitis
Sicca Syndrome; Keratoconjunctivitis (Etiology)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-06-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will enroll charts following a pre-identified process.

Brief summary: This study will be used to support assessment of AIR OPTIX® NIGHT \& DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.

Detailed description: In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.

Eligibility criteria: Key Inclusion Criteria:

* Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) at Baseline.
* Baseline and Follow-up (up to 1 year from Baseline) charts available.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator.
* Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in corneal pain at the Follow-up Visit
timeFrame: Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Franklin Park
country: United States
facility: Franklin Park Eye Center PC
state: Illinois
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02232906: Switch From Oral Iron to Intravenous Ferric Carboxymaltose in Non-dialysis Chronic Kidney Disease (CKD)
Official title: Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency
Anaemia
Keywords: Chronic kidney disease
CKD
non-dialysis-dependent
ND-CKD
Erythropoiesis-stimulating agent
Ferric carboxymaltose
Iron
Lead sponsor: Hospital Aleman
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2014-09-05
Enrollment: 30
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: Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Creatinine clearance ≤40 mL/min
* Hemoglobin 110-120 g/L
* Serum ferritin \<100 µg/L or transferrin saturation \<20%
* Monthly treatment with ESA and oral iron for at least six months before enrolment

Exclusion Criteria:

* Other obvious cause of acute or chronic anemia than iron deficiency
* Expectation to require hemodialysis within the next six months
* Short life expectancy (\<1 year)
* Pregnancy
* Decompensated heart failure
* History of allergic reactions to iron preparations and/or anaphylaxis from any cause
* Requirement of blood transfusions
* Chronic decompensated mental disorder or dementia

Primary outcomes:
measure: ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
timeFrame: 6 months
Secondary outcomes:
measure: Anaemia and iron status
timeFrame: 6 months
measure: Number of hospitalizations
timeFrame: 6 months
measure: Number of transfusions
timeFrame: 6 months
measure: Number of adverse reactions
timeFrame: 6 months
measure: Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function
timeFrame: 6 months
measure: Proteinuria at baseline and then bi-monthly until end of study as marker of renal function
timeFrame: 6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Alemán
Study officials:
affiliation: Hospital Aleman
name: Jorge E Toblli, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toblli JE, Di Gennaro F. Switching patients with non-dialysis chronic kidney disease from oral iron to intravenous ferric carboxymaltose: effects on erythropoiesis-stimulating agent requirements, costs, hemoglobin and iron status. PLoS One. 2015 Apr 30;10(4):e0125528. doi: 10.1371/journal.pone.0125528. eCollection 2015.
Clinical trial NCT05963906: Food Survey, Curbside, Remote APPs SCFI
Official title: An Innovative, Accessible, and Flexible Approach for Household Food Waste Measurement - SCFI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Sciences
Climate
Recycling
Waste Management
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: Martin, Corby, K., M.D.
First posted: 2023-07-27
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be from the greater Columbus, OH and Baton Rouge, LA areas.

Brief summary: The proposed research will create accurate and standardized household food waste measurement technologies that foster serial and longitudinal assessments as well as confident and convenient one-time measurement. The investigators propose the SCFI field study where participants simultaneously deploy 3 measurement approaches (1) retrospective surveys (2) curbside audits, and (3) the FoodImage smartphone app.


Eligibility criteria: Inclusion Criteria:

* Male or Female, age 18-64 years
* Willing and able to store household food waste for curbside pickup by a third-party waste pickup company
* Internet or Wi-Fi availability to complete online surveys
* Ownership of an IPhone 9s or later, operable Apple ID, password, and email address that they are willing and able to use to collect data during the study. Subject acknowledges data usage and associated charges are a result of study
* Willing to complete all study procedures and adhere to study visit timelines

Exclusion Criteria:

* Not willing to adhere to study procedures and study visit timelines
* Any condition or circumstance that in the judgement of the PI could interfere with study participation

Primary outcomes:
measure: Household Food Waste
timeFrame: 1 week
measure: Household Food Waste
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Pennington Biomedical Research Center
name: John W Apolzan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06210906: Gastric Volume Following Sips of Water Intake
Official title: Gastric Volume Following Sips of Water Intake Within 1 Hour in Preoperative Fasting Elderly Patients; Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stomach Filling
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 65 years old undergoing elective surgery under general anesthesia

Brief summary: We aim to observe whether drinking of sips of water within 1 hour before surgery significantly affects the gastric volume.


Eligibility criteria: Inclusion Criteria:

* Patients over 65 years old undergoing elective surgery under general anesthesia

Exclusion Criteria:

* History of gastric surgery
* Anatomical anomaly, diseases, or mass in the stomach

Primary outcomes:
measure: Gastric volume
timeFrame: Immediately before induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05429606: Effect of Different Conductive Media on the Efficacy of Electric Pulp Tester
Official title: Effect of Different Water-based and Gel-based Conductive Media on the Efficacy of Electric Pulp Tester
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Maxillary Central Incisors
Lead sponsor: Pakistan Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2022-06-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects are dental students of School of dentistry Islamabad

Brief summary: Dental pulp tests are investigations that offer valuable diagnostic and treatment planning information to the dental clinician. EPT is a sensibility test that can be easily performed in clinical practice. Current study is to find the best conducting substance among readily available water-based gels and gel-based tooth pastes to evaluate the efficacy of electric pulp tester.

Detailed description: The study will be performed on dental students with written informed constant. The sample size of study is 100. There will two main groups of conductor materials used in the study: water-based gels (fluoride gel, electrode gel and chlorohexidine gluconate) and gel-based toothpastes (Colgate and Dentonic Ultrawhitening gel). All groups will be randomly applied to the same patient at a single visit. Two measurements will be recorded for each material and the average value of the two measurements will used. Then, the measurements will record, and a comparison will be made between different conductors.

Eligibility criteria: Inclusion Criteria:

* Healthy fully erupted teeth maxillary central incisors.
* Study subjects above 18 years.
* No systemic diseases and pregnancy

Exclusion Criteria:

* Carious, decayed and periodontally affected teeth.
* Taking anti-inflammatory drugs from last 2 weeks.
* Taking cortisone for the last 6 month

Primary outcomes:
measure: Efficacy of electric pulp tester
timeFrame: immediately after procedure
Secondary outcomes:
measure: Effect of gender on efficacy of electric pulp tester.
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad
state: Islamabad Capital Territory
Study officials:
affiliation: School of dentistry PIMS
name: nosheen sarwar, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01545206: Dose Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction Cause Less Cost?
Official title: Better Quality With Less Cost? A Single Hospital Experience on Reducing Door-to-balloon Time in ST-elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute STEMI
Primary Percutaneous Coronary Arterial Intervention
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-03-06
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient presented between Feb. 1, 2007 and Jul. 31, 2009 at Far Eastern Memory Hospital for acute STEMI and unwent primary PCI.

Brief summary: The investigators tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.

Detailed description: The relationship between the quality of care and costs has been discussed widely. Higher costs of care did not bring better outcomes, vice versa. However, as the rising spending of health care, the health care providers, insurance payers, governments, and consumers begin to pursue the higher quality of cares with lowest costs. In surgical experiences, improving the process of care succeeded to improve the quality of care and reduce the costs.

In patients with acute ST-Segment elevation myocardial infarction (STEMI), A Door-to-Balloon (D2B) time of less than 90 minutes has been established as the gold standard for primary percutaneous coronary intervention (PCI) and was associated with lower in-hospital mortality.9 Only less literatures discussed the costs and the quality of care in acute STEMI, and whether improving processes of care associated with lower costs was still controversial. The Premier Hospital Quality Incentive Demonstration (PHQID) in United State improved the processes of care but had not a significant effect on cost. Another single hospital experience in Indiana, USA, showed that the reducing D2B time in STEMI decreased the insurance payments as well as the total hospital costs. However, this study design was before-and-after intervention analysis, did not actually measure the impact of D2B time. Besides, the payment system in this study was prospective payment, not fee-for-service payment in Taiwan.

In this study, we tried to determined whether the less D2B time led to costs savings benefited insurance payer and better outcomes to patients.

Eligibility criteria: Inclusion Criteria:

* self visit
* acute STEMI by ECG definition

Exclusion Criteria:

* non-diagnosis on first ECG
* transferred
* diagnostic angiogram only

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Chieh-Min Fan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847906: Evaluating the Reach of Clinical Decision Support for Patients With Heart Failure
Official title: Evaluating the Reach of Clinical Decision Support for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decision Support Systems, Clinical
Heart Failure
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Heart Association (AHA)
First posted: 2025-02-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare two different types of a virtual CDS tool in a randomized pilot study at one health system.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To work best, clinical decision support tools (CDS) must be timed to provide support when healthcare decisions are made, which includes virtual visits (phone or video). Unfortunately, most CDS tools are either missing from virtual visits or not designed for the unique context of virtual visits (e.g., availability of physical assessments and labs, different workflows), which could generate new inequities for patients more likely to use virtual visits. The objective of this study is to test the reach, feasibility and acceptability of a new CDS tool for heart failure with reduced ejection fraction (HFrEF) during virtual visits. This new CDS tool was developed through an iterative design process, and will be compared to an existing HFrEF CDS tool in a randomized pilot study at outpatient cardiology clinics throughout the UCHealth system.


Eligibility criteria: Inclusion Criteria:

* The study subjects are potential users of the CDS, specifically clinicians with prescribing privileges who practice at one of the health system's (UCHealth) outpatient cardiology clinics. Because we are observing their prescribing behaviors in a virtual care setting (phone or video), we are also evaluating patient characteristics which could influence their prescribing decisions.

Exclusion Criteria:

* Clinicians who do not practice in a UCHealth cardiology clinic.

Primary outcomes:
measure: Number of CDS alerts resulting in the prescription of a recommended medication
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients the CDS alerted for
timeFrame: 6 months
measure: Number of times a prescriber ordered at-home vitals
timeFrame: 6 months
measure: Number of patients who upload their vitals in the patient portal
timeFrame: 9 months
measure: Number of alerts that were not outright dismissed
timeFrame: 6 months
measure: Number of prescription orders for guideline directed medical therapy (GDMT) for heart failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth Primary Care and Cardiology Outpatient Clinics
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Katy Trinkley, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06980506: MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer
Official title: Imaging of Patients With Solid Tumor Cancer Via Intermediate-Size Patient Population Expanded Access Investigational New Drug (IND)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cancer
Solid Tumor
Solid Tumor, Adult
Keywords: Solid Tumor
PET/CT
urokinase plasminogen activator receptor
uPAR
Zirconium-89 imaging
Positron emission tomography/computed tomography
MNPR-101-DFO*-89Zr
uPAR-positive
Urokinase plasminogen activator receptor-positive
EAP IST-00Cb
Antibody radionuclide conjugate
Monoclonal antibody radionuclide conjugate
Solid tumor imaging
Lead sponsor: Monopar Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-05-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this Expanded Access Program (EAP) is to allow use of the investigational imaging agent, MNPR-101-DFO\*-89Zr, with positron emission tomography/computed tomography (PET/CT) imaging, to non-invasively detect the presence of urokinase plasminogen activator receptor (uPAR) binding in solid tumors. uPAR binding is higher in tumors compared to normal tissue in some cancers.

Detailed description: Imaging agent MNPR-101-DFO\*-89Zr will be dosed to adult patients diagnosed with solid tumor cancer followed 3 to 5 days later by PET/CT imaging. The result will determine if there is sufficient uPAR binding, as assessed by the Investigator, to support administration of the companion intervention MNPR-101-PCTA-177Lu in a separate expanded access program (EAP IST-00Cb). The safety of MNPR-101-DFO\*-89Zr will be evaluated as will the amount of radioactivity present in blood samples.

Eligibility criteria: Key Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic solid tumor cancer that is refractory to existing therapy(ies) known to provide clinical benefit, or for which no standard treatment is available, or is contraindicated
* Ability to understand and willingness to sign a written informed consent document

Key Exclusion Criteria:

* Continuing ≥ Grade 3 adverse reactions from prior systemic therapy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0)
* Prior treatment with any radiopharmaceutical or investigational agents within 4 weeks or 5 half-lives, whichever is longer, prior to administration of MNPR-101-DFO\*-89Zr
* Evidence of impaired organ function, particularly bone marrow, liver, kidney, or heart, according to specific test parameters
* Presence of other serious, non-malignant diseases or any other condition that, in the opinion of the investigator, could interfere with the objectives of the study, participant safety, or compliance.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Excel Diagnostics & Nuclear Oncology Center
state: Texas
Study officials:
affiliation: Excel Diagnostics & Nuclear Oncology Center
name: Ebrahim S. Delpassand, M.D. Chairman & Medical Director, Nuclear Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04111406: Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
Official title: Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epidural Analgesia
Postoperative Pain
Keywords: Epidural Analgesia
Postoperative Pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019
Primary purpose: PREVENTION

Brief summary: Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.

Detailed description: A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

Eligibility criteria: Inclusion Criteria:

* All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.

Exclusion Criteria:

* Coagulopathy
* Allergy to study drugs: local anesthetics and opioids
* History of chronic pain

Primary outcomes:
measure: Overall incidence of inadequate epidural analgesia
timeFrame: 72 hours
Secondary outcomes:
measure: Side effects
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital
name: Pawinee Pangthipampai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: