louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02782117: Luminopia One Pilot Study
Official title: Luminopia One Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Lead sponsor: Luminopia
Sponsor class: INDUSTRY
Collaborators: name: Boston Children's Hospital
First posted: 2016-05-25
Enrollment: 84
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
Primary purpose: TREATMENT

Brief summary: A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.


Eligibility criteria: Major Eligibility Criteria:

* Age 4 to \<8 years (phase 1) or age 4 to \<13 years (phase 2)
* Monocular amblyopia associated with anisometropia, strabismus or both combined
* Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)
* Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)
* Interocular BCVA difference ≥3 lines (≥0.3 logMAR)
* Visual acuity stability in current refractive correction (phase 2)
* Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)

Primary outcomes:
measure: Amblyopic eye best-corrected visual acuity
timeFrame: 12 weeks
Secondary outcomes:
measure: Amblyopic eye best-corrected visual acuity
timeFrame: 8 weeks
measure: Amblyopic eye best-corrected visual acuity
timeFrame: 4 weeks
measure: Adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Eye Physicians of Central Florida
state: Florida
city: Chicago
country: United States
facility: Wheaton Eye Clinic
state: Illinois
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Frederick
country: United States
facility: Kids Eye Care of Maryland
state: Maryland
city: Dearborn
country: United States
facility: Children's Eye Care of Michigan
state: Michigan
city: Concord
country: United States
facility: Concord Eye Center
state: New Hampshire
city: Lancaster
country: United States
facility: Conestoga Eye
state: Pennsylvania
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Virginia Beach
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
Study officials:
affiliation: Boston Children's Hospital
name: David Hunter, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02295917: Computerized Evaluation of the Endometrial Myometrial Junction During a Natural Menstrual Cyle.
Official title: The Investigators Aim to Evaluate the Width of the Endometrial Myometrial Zone in Participants During Natural Menstrual Cycle by Using Specific Computerized Application on 3 Dimensions Sonographic Images of Their Uteri
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients referred for transvaginal sonography

Brief summary: The investigators aim to evaluate the width of the endometrial myometrial zone in participants during natural menstrual cycle by using specific computerized application on 3 dimensions sonographic images of their uteri.

Detailed description: The uterine endometrium and the uterine myometrium have different acoustic characterization in transvaginal ultrasound(TVS).TVS can also demonstrate the interface between these tissues - the endometrial myometrial zone(EMJ) .This is optimally achieved in 3 dimensions images in a coronal section of the uterus.A specific computerized algorithm was developed in our unit by using MATLAB software for the quantitative measurements of the EMJ width in different uterine planes.The investigators aim to evaluate changes in the width of the EMJ in different uterine planes in participants during natural menstrual cycle .

Eligibility criteria: Inclusion Criteria:patients with regular menstrual cycles -

Exclusion Criteria:patients on contraceptive pills.patients after uterine surgery

-

Primary outcomes:
measure: Changes in the width of the EMJ during natural cycle
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Rami Aviram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00782717: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
Official title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Edema
Keywords: diabetic retinopathy
cystoid macular edema;
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: 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 nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.


Eligibility criteria: Inclusion Criteria:

* Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Central subfiled macular thickness greater than or equal to 250 microns
* CME in either eye.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
timeFrame: 3 Months
Secondary outcomes:
measure: Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
timeFrame: From Day 7 to Day 90 (or Early Exit)
Other outcomes:
Locations:
Study officials:
References:
citation: Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3.
citation: Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.
Clinical trial NCT04443517: Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia
Official title: Modulation Of Frontal EEG Alpha Oscillations During Maintenance and Emergence Phases of General Anesthesia to Improve Early Neurocognitive Recovery in Older Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Delirium
Keywords: EEG
General Anesthesia
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators intend to recruit 600 participants to see if alpha power during anesthesia is influenced by analgesic medication and associated with a reduction of delirium following surgery.

Detailed description: Postoperative delirium may manifest in the immediate post-anesthesia care period. Such episodes appear to be predictive of further episodes of inpatient delirium and associated adverse outcomes. Intraoperative monitoring of frontal electroencephalogram (EEG) has been associated with postoperative delirium and poor outcomes. However, the efficacy of titrating anesthesia medication to proprietary index targets for preventing delirium remains contentious. The investigators aim to assess the efficacy of two pharmacologic strategies which could prevent post-anesthesia care unit (PACU) delirium (1) maximization of intraoperative alpha power during maintenance and (2) switching anesthesia regimes during the emergence phases of anesthesia.

Eligibility criteria: Inclusion Criteria:

* Adults aged 60 years or over
* Has capacity to provide informed consent
* Undergoing elective non-cardiac surgery, which does not involve the head or neck, with planned volatile-based general anesthesia of expected duration of at least 2 hours

Exclusion Criteria:

* Chronic pain with opioid requirement or concurrent use of enzyme inducers, e.g. carbamazepine, phenytoin,
* Illicit substance use or excessive alcohol intake
* Refusal by patient or case anesthesiologist responsible for patient's care

Primary outcomes:
measure: Change in Frontal Alpha Power
timeFrame: Up to 24 hours post-surgery
Secondary outcomes:
measure: Incidence of PACU Delirium
timeFrame: Up to 24 hours post-surgery
measure: Change in pain in PACU: numerical rating score (NRS)
timeFrame: Up to 24 hours post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Paul S. Garcia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03636217: Effect of Kefir on Appetite
Official title: Effect of Kefir on Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Keywords: Appetite
Probiotic
Glycemic index
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: This study aimed to determine the effect of kefir on appetite in healthy subjects. A randomized, single-blind, and 3-intervention crossover trial included 22 healthy and normal-weight (BMI 18.5-25 kg/m2) females aged 21-24 years. Participants were recruited to three test meals: an LGI-Milk, an LGI-Kefir, and an HGI-Kefir, with a one-week washout period. Appetite ratings were measured at 0, 15, 30, 60, 90, 120, 150, and 180 minutes. At the end of three hours, participants were served an ad libitum lunch meal. Then, the foods eaten at lunch were recorded and their energy and nutrient analysis was calculated.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Normal-weight (BMI 18.5-25 kg/m2)
* Female
* 21-24 years

Exclusion Criteria:

* During the last three months, change more than 5 kg in body weight or following an energy-restricted diet
* Being a vegan
* Having any chronic diseases such as diabetes, hypertension, etc.
* Physician-diagnosed medications or conditions that influence metabolism
* Smoking
* Practicing endurance sports
* Having difficulties with swallowing/eating
* Lack of appetite
* Hypersensitivity for the foods understudy
* Pregnant or lactating

Primary outcomes:
measure: Hunger rating
timeFrame: Three hours postprandial period
measure: Fullness rating
timeFrame: Three hours postprandial period
measure: Desiring to eat
timeFrame: Three hours postprandial period
measure: Prospective food consumption
timeFrame: Three hours postprandial period
measure: Composite appetite score
timeFrame: Three hours postprandial period
measure: Subsequent energy consumption
timeFrame: Three hours after the test breakfast
Secondary outcomes:
measure: Desiring for sweet
timeFrame: Three hours postprandial period
measure: Desiring for salty
timeFrame: Three hours postprandial period
measure: Desiring for savoury
timeFrame: Three hours postprandial period
measure: Desiring for fatty
timeFrame: Three hours postprandial period
measure: Visual appeal of test meal
timeFrame: Immediately after consuming test meal (at 15 min)
measure: Smell of test meal
timeFrame: Immediately after consuming test meal (at 15 min)
measure: Taste of test meal
timeFrame: Immediately after consuming test meal (at 15 min)
measure: Aftertaste of test meal
timeFrame: Immediately after consuming test meal (at 15 min)
measure: Palatability of test meal
timeFrame: Immediately after consuming test meal (at 15 min)
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Health Sciences
Study officials:
References:
Clinical trial NCT02519517: Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
Official title: Acute Permissive Hypercapnia During One Lung Ventilation: Impact on Right Ventricular Systolic and Diastolic Functions During Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Investigators studied 15 patients scheduled for pulmonary resection through thoracotomy. Initial tidal volume (VT) 10ml kg-1 was reduced to 8ml kg-1 after one lung ventilation (OLV) and the rate adjusted to maintain partial pressure of arterial carbon dioxide (PaCO2) 30-35 mm Hg. Data were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH \>7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures analysis of variance (ANOVA), with post hoc Dunnet´s test were used for analysis. A P value \< 0.05 is considered statistically significant.

Detailed description: Investigators studied 15 patients scheduled for elective pulmonary resection through thoracotomy. Patients had a standardized management for thoracotomies. Initial VT 10ml/ kg was reduced to 8ml/kg after OLV and the rate adjusted to maintain PaCO2 30-35 mm Hg. Haemodynamic, respiratory variables and echocardiographic data (Tei index and TAPSE) were obtained at: T1, 15 min post establishing OLV with normocapnia, T2, 15 min post establishing OLV with hypercapnia (PaCO2 7.98kPa (60mmHg) and 9.31kPa (70mmHg) and pH \>7.1), and T3, 15 min after resuming OLV with normocapnia. One-way repeated measures ANOVA, with post hoc Dunnet´s test were used for analysis. A P value \< 0.05 is considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* adult \>18 yr
* elective pulmonary resection through thoracotomy.

Exclusion Criteria:

* Patients with pulmonary hypertension (systolic \>50mmHg),
* intracranial hypertension or previous intracranial haemorrhage,
* pre-existing hypercapnia,
* co-existing metabolic acidosis,
* ischaemic heart disease,
* predicted postoperative FEV1\<800 ml or \<40% of the expected in pneumonectomy
* patient in which transesophageal echocardiography was contraindicated or necessary measurements were difficult to assess.

Primary outcomes:
measure: Right ventricular systolic and diastolic functions measured by Tei index
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06619717: Optimal Number of Hyperbaric Oxygen Treatments for Carbon Monoxide Poisoning
Official title: Optimizing Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning: An Open-label Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperbaric Oxygen Therapy
Carbon Monoxide Poisoning
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The optimal treatment strategy with hyperbaric oxygen therapy has been the subject of some debate over the past 3 decades. Initial landmark studies showed a decrease in the incidence of DNS with a single treatment and also with three treatments over the course of 24 hours. These two strategies have continued to be used widely without further evidence comparing them in a direct fashion. Retrospective publications in the years since have been largely conflicting about the benefit of additional hyperbaric treatments. The investigators would seek to randomize patients with carbon monoxide poisoning to receive with 1 or 3 treatments with hyperbaric oxygen and measure their neurologic outcomes.

Detailed description: HBO is a niche treatment modality, especially in Canada. There are few sites which offer this care, and as such, treatment often carries significant logistical challenges. Since 2021, the HBO unit at the Misericordia hospital has averaged 49 patients per year being treated for CO poisoning. This HBO unit provides coverage to patients within Alberta, Saskatchewan, Manitoba, Yukon, and Northwest Territories. Due to the significant barriers to treatment, including the high cost to the public system, it is important to clearly understand how to best treat these patients.

Purpose:

The aim of this study is to assess whether a single treatment session of hyperbaric oxygen is non-inferior to three treatments for patients with acute carbon monoxide poisoning.

Eligibility criteria: Inclusion Criteria:

* All adult (over 17 years old) patients referred to a Hyperbaric Unit for acute carbon monoxide poisoning.

Exclusion Criteria:

* Obtunded
* Mechanically ventilated
* Pregnant
* Incarcerated
* Cognitively impaired (acutely or chronically)

Primary outcomes:
measure: Proportion of patients experiencing delayed neurologic sequalae
timeFrame: 6 weeks and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Professor in the Department of Emergency Medicine, Faculty of Medicine &amp; Dentistry, College of Health Sciences, at the University of Alberta
name: Brian Rowe, MD, MSc, CCFP (EM), FCCP
role: STUDY_DIRECTOR
References:
Clinical trial NCT00581217: A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings
Official title: A Randomized Comparison Study of Aquacel Ag and Glucan II as Donor Site Dressings With Regards to Healing Time, Cosmesis, Infection Rate, and Patient's Perceived Pain: a Pilot Study.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Burns
Keywords: Burn injury
Skin graft
Donor site dressing
Outcomes
Infection rate
Healing time
Cosmetic Result
Pain
Burn injured patients requiring skin grafting
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Burn injured patients or patients who have had full thickness skin loss requiring skin grafting and donor site dressings

Brief summary: The research will be looking at patient outcomes for healing of donor sites after a split-thickness skin graft procedure for a burn or skin tissue loss. Donor site healing time, infection rate, cosmetic outcome, and patient's rating of pain will be compared between two donor site dressings, Glucan II and Aquacel Ag.


Eligibility criteria: Inclusion Criteria:

* Adults over age 18 who have sustained a 1 - 30% total body surface area burn or skin tissue loss and require skin grafting

Exclusion Criteria:

* Individuals under the age of 18.

Primary outcomes:
measure: Healing time
timeFrame: 7 - 14 days
Secondary outcomes:
measure: Infection rate
timeFrame: 1-21 days
measure: Cosmetic outcome
timeFrame: 6 months
measure: Pain rating
timeFrame: 6 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Marianne E Cinat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Suzanne Bailey, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Melissa Carmean, PT, CWS, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677117: Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ECMO Treatment
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: severe ARDS patients

Brief summary: Acute respiratory distress syndrome (acute respiratory distress syndrome, ARDS) fatality rate can be as high as 20% -41%, once progress is severe of ARDS, mortality rose to 90%, the main cause of death was refractory hypoxemia. Mechanical ventilation as the main measure to improve hypoxemia cannot correct all hypoxemia and relating complications of mechanical ventilation, mechanical ventilation in the treatment of severe ARDS has gradually been challenged. Extracorporeal membrane oxygenation（ECMO) technology matures, so that clinicians have more choices in the face of hypoxemia, and with the deepening understanding of ECMO, ECMO may become severe ARDS first-line treatment. Currently, ECMO therapy has been recognized by the majority of medical workers. Therefore, we assume that accurately grasping the ECMO indications and standardizing the implementation of treatment can significantly improve the prognosis, shorter hospital stays, lower hospitalization costs.


Eligibility criteria: Inclusion Criteria:

(1) age 18-70 years; (2) severe respiratory dysfunction (Murry score ≥ 3 points or clinical optimized ventilation conditions pH remains \<7.2 patients); (3) PaCO2/FiO2 \<100mmHg; (4) plateau pressure \>30cmH2O more than 6h，duration of no more than seven days; (5) with severe respiratory dysfunction etiology reversible.

Exclusion Criteria:

(1) high levels pressure mechanical ventilation (PEEP\> 15-20cmH2O and / or Pplat\> 35-40cmH2O) over 7 days; (2) continued to receive high concentrations of oxygen (FiO2\> 80%) is more than 7 days; (3) severe active bleeding; (4) within 24 hours of the surgery or head injury with intracranial bleeding; (5) a variety of serious irreversible state; (6) malignancy; (7) progressive pulmonary fibrosis; (8) can not surgical problems; (9) due to cardiac dysfunction leading to ARDS.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: