louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05608980: 0.01% Hypochlorous Acid in the Treatment of Blepharitis
Official title: Effect of Hypochlorous Acid on Blepharitis Through Ultrasonic Atomization: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharitis
Keywords: Blepharitis
Hypochlorous Acid
Eyelid cleanser
Eyelid hygiene
Meibomian gland dysfunction
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: ShuGuang Hospital
First posted: 2022-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, controlled, randomized study.
Primary purpose: TREATMENT

Brief summary: This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.


Eligibility criteria: Inclusion Criteria:

1. Age 18 or older.
2. Anterior or mixed (anterior + posterior) blepharitis.
3. Similar clinical condition of both eyes.
4. A negative urine pregnancy test result for women of childbearing potential
5. Normal lid position and closure
6. Ability to understand and provide informed consent to participate in this study
7. Willingness to follow study instructions and likely to complete all required visits.

Exclusion Criteria:

1. Any ocular surface disease other than blepharitis.
2. Known allergy to hypochlorous acid or boric acid.
3. Eye surgery in the last 6 months.
4. History of Stevens-Johnson syndrome or ocular pemphigoid
5. Ocular trauma in the last 6 months.
6. Use of contact lenses in the last 6 months.
7. Pregnancy or lactation.
8. Daily use of makeup on lashes.
9. Any ocular or systemic medication that might affect the ocular microbiota (antibiotics, immunosuppressants, steroids).
10. Pregnant or lactating women
11. Signs of current infection, including fever and current treatment with antibiotics
12. Liver, renal, or hematologic disease
13. The use of any other investigational drug

Primary outcomes:
measure: OSDI
timeFrame: Change from baseline OSDI at 2 weeks
measure: meibum quality
timeFrame: Change from baseline meibum quality score at 2 weeks
measure: Corneal fluorescein staining
timeFrame: Change from baseline corneal fluorescein staining at 2 weeks
measure: FBUT
timeFrame: Change from baseline FTBUT at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye & ENT Hospital of Fudan University
name: Jiaxu Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06867380: An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Official title: A Feasibility, Prospective, Repeated-measures Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients: A Master Umbrella Investigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cochlear Implant Recipients
Hearing Loss, Cochlear
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.


Eligibility criteria: Inclusion Criteria:

* Users of an approved Nucleus cochlear implant.
* Aged 18 years or older (no upper age limit).
* Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Primary outcomes:
measure: Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy
timeFrame: 0 to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: HEARnet Clinical studies
state: Victoria
city: East Melbourne
country: Australia
facility: Cochlear Melbourne
state: Victoria
Study officials:
References:
Clinical trial NCT01546480: From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests
Official title: From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Chronic postoperative pain
Postcholecystectomy pain
Inflammation
Interleukines
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
name: Oberstinde Kirsten Jensa la Cours Foundation
First posted: 2012-03-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain.

Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres.

Brief summary: Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation.

The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation.

DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.


Eligibility criteria: Group 1:

Inclusion Criteria:

* Unexplained abdominal pain 12 months after elective cholecystectomy

Exclusion Criteria:

* Immunosuppressive treatment (NSAID excepted)
* Anticoagulant treatment

Group 2:

Inclusion Criteria:

* No pain 12 months after elective cholecystectomy

Exclusion Criteria:

* Immunosuppressive treatment (NSAID excepted)
* Anticoagulant treatment

Group 3:

Inclusion Criteria:

* Elective operation in spinal anesthesia or
* Or healthy volunteers accepting samples of blod, cerebral spinal fluid and saliva, to be collected

Exclusion Criteria:

* Acute or chronic pain condition
* Immunosuppressive treatment (NSAID excepted)
* Previous abdominal operation

Primary outcomes:
measure: Spinal interleukine levels
timeFrame: 12 months
Secondary outcomes:
measure: Blood interleukine levels
timeFrame: 12 Months
measure: spinal enzyme levels
timeFrame: 12 months
measure: Blood enzyme levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Lillebælt Hospital
Study officials:
References:
Clinical trial NCT02964780: Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
Official title: Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity class 3 who want to reduce weight

Brief summary: The main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. In addition, we want to evaluate the postprandial hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.

Secondary objectives are investigating determinants for the changes in sex steroids, liver disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion patterns, body composition, resting metabolism rate, weight loss per se and changes in fat distribution, parameters of fatty acid metabolism, ... .


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained
* BMI \> 35 kg/m²

Exclusion Criteria:

* Primary or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
* Type 2 Diabetes Mellitus treated with insulin or GLP-1 analogues
* Current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics
* Cancer (within \< 5 years)
* High-grade malignancies
* Serious co-morbidities such as renal, hepatic of cardiac failure
* Known or suspected abuse of alcohol or narcotics
* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.

Primary outcomes:
measure: Change from baseline in sex steroids
timeFrame: Baseline, 3 weeks, 6 weeks, 6 months, 1 year.
measure: Change from baseline in liver fat
timeFrame: Baseline, 6 months, 1 year
measure: Correlation in changes in liver fat en changes in sex steroids
timeFrame: baseline, 6 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Endocrinology, UZ Ghent Hospital
Study officials:
References:
Clinical trial NCT02015429: Effect of Yellow Pea Protein and Fibre Added to a High-carb Meal on Glycemic Response and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Keywords: Food intake
satiety
glycemia
appetite
blood glucose
yellow peas
fibre
protein
mixed meal
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesized that consuming isolated yellow pea fibre or protein, alone to together, as part of a high-carbohydrate pasta meal, would reduce the blood glucose response to the meal compared to a meal without yellow pea components and reduce food intake at a meal served 2 hours later.


Eligibility criteria: Inclusion Criteria:

* Non-smoking
* No metabolic disease
* BMI 20 - 25 kg/m\^2
* male
* age 20-30

Exclusion Criteria:

* Intolerance to treatments
* on appetite-modifying medications
* restrictive eating
* smoking
* over or underweight
* breakfast-skipping

Primary outcomes:
measure: Ad libitum food intake at second pizza meal
timeFrame: 135 mins after completion of treatment, 20 mins to eat pizza meal.
measure: Blood glucose
timeFrame: between 0 and 215 mins, every 15-30 mins
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0 to 215 minutes
Other outcomes:
measure: Palatability of treatments
timeFrame: following treatment consumption at 15 mins
Locations:
city: Toronto
country: Canada
facility: University of Toronto - Department of Nutritional Sciences
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Harvey G Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04528329: Anosmia and / or Ageusia and Early Corticosteroid Use
Official title: Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Covid19
Anosmia
Lead sponsor: ClinAmygate
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 300
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: Time to recover of Anosmia and / or ageusia and early corticosteroid use

Detailed description: In a study of dexamethasone kinetics in two groups of 15 patients with community-acquired pneumonia, one group was treated with dexamethasone 6 mg/day by mouth and the other with 4 mg/day intravenously. The apparent volume of distribution was 1 L/kg in both groups, but the half-life after oral administration was approximately 7 hours, and after intravenous administration 9 hours. The bioavailability of oral dexamethasone was 81% (95% CI = 54-121%). However, the biological half-life of dexamethasone is much longer, of the order of 36-54 h compared with 18-36 h for prednisolone.

Time to recover of Anosmia and / or ageusia and early corticosteroid use

Eligibility criteria: Inclusion Criteria:

* Any case with COVID-19
* Age more than or equal to 18 years
* Mild to moderate severity

Exclusion Criteria:

* Diabetes
* Any contra-indication for the interventional drug
* Mentally disabled cases

Primary outcomes:
measure: Time to recovery
timeFrame: one to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Asalam
state: Cairo
Study officials:
affiliation: Assalam Clinics
name: Emad R Issak, MD
role: STUDY_DIRECTOR
References:
citation: Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.
Clinical trial NCT00369980: Diagnostic Usefulness of Fluorine-18-α-Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
Lead sponsor: Gunma University
Sponsor class: OTHER
First posted: 2006-08-30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: L-\[3-18F\]-α-methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET), and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the increased expression of amino-acid transporter. This study was conducted to investigate a usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in patients with suspected malignancy.


Eligibility criteria: Inclusion Criteria:

* Eligible patients were required to have histologically proven noncaseating epithelioid cell granuloma and at least one disease that the possibility of coexistent malignancy could not be excluded as follows; 1) extrapulmonary lesions mimicking malignant diseases including systemic lymphadenopathy, hepatosplenic involvement, or other lesions, 2) multiple nodular lesions mimicking pulmonary metastasis, 3) the occurrence of BHL in cancer patient.

Exclusion Criteria:

* The patients that PET imaging using 18F-FDG and 18F-FMT was performed before establishment of the final diagnosis of sarcoidosis, patients undergoing treatment for sarcoidosis before the PET study, and patient having diabetes mellitus.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gunma
country: Japan
facility: Gunma University Graduate School of Medicine
Study officials:
affiliation: Gunma University Graduate School of Medicine
name: kyoichi kaira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaira K, Oriuchi N, Otani Y, Yanagitani N, Sunaga N, Hisada T, Ishizuka T, Endo K, Mori M. Diagnostic usefulness of fluorine-18-alpha-methyltyrosine positron emission tomography in combination with 18F-fluorodeoxyglucose in sarcoidosis patients. Chest. 2007 Apr;131(4):1019-27. doi: 10.1378/chest.06-2160.
Clinical trial NCT00717080: The Role of Capsular Tension Ring (CTR) in Anterior Capsular Contraction
Official title: Role of Capsular Tension Ring in Anterior Capsular Contraction in Retinitis Pigmentosa Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinitis Pigmentosa
Cataract
Keywords: Retinitis Pigmentosa
Cataract
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized Controlled Trial to study the role of Capsular Tension Ring in patients with Retinitis Pigmentosa

Detailed description: Cataract is a common complication in retinitis Pigmentosa (RP) patient especially posterior sub capsular cataract. Continuous curvilinear capsulorhexis is the preferred method of capsulotomy in cataract surgery. Anterior capsular contraction (ACO) is a unique complication following cataract surgery. The rate of which is higher in RP patients due to the weak zonules and the increased rate of inflammation. CTR has been proven to reduce the rate of contraction.

Study population includes 40 eyes having RP with cataract. 20 eyes will receive CTR and the other 20 would not receive CTR. The percentage of anterior capsular contraction would be evaluated using EPCO software.

Eligibility criteria: Inclusion Criteria:

* Age 35 to 65 years
* Typical retinitis pigmentosa
* Reside within a radius of 100kms from Madurai
* Patients willing to come for follow up
* Patients with nuclear sclerosis grade 2 or 3 or cortical cataract or pscc

Exclusion Criteria:

* Diabetic patients
* Traumatic cataract
* Uveitis
* Glaucoma
* Pseudoexfoliation
* Myotonic dystrophy
* Corneal pathology
* Pupil size \<6mm
* Intra op complications like zonular dialysis,pc rupture
* Rhexis not covering iol optic

Primary outcomes:
measure: The percentage of anterior capsular contraction
timeFrame: 1 day, 30 days,90 days,180 days,270days
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 day, 30 days,90 days,180 days,270days
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Haripriya Aravind, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759980: Transfusing Neonates Based on Platelet Mass
Official title: Transfusing Neonates Based on Platelet Mass in the Neonatal Intensive Care Unit: A Randomized Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Keywords: Thrombocytopenia
Platelet transfusion
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Alfred I. duPont Hospital for Children
name: Thomas Jefferson University
name: Abington Memorial Hospital
First posted: 2008-09-25
Enrollment: 50
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who are thrombocytopenic and hospitalized in the NICU

Brief summary: Thrombocytopenia (low platelet count) is common in the neonatal intensive care unit. Commonly, the decision of when to transfuse platelets is based on platelet number. Recently, Christensen et al (2006) proposed using transfusion guidelines based on platelet mass rather than platelet number. By using platelet size as a guide of when to give platelets, we may be able to decrease the amount platelet transfusions needed.

This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules.

The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number.

The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.


Eligibility criteria: Inclusion Criteria:

* Thrombocytopenic infants

Exclusion Criteria:

* Major congenital anomalies

Primary outcomes:
measure: Total number of transfusions
timeFrame: During NICU hospitalization
Secondary outcomes:
measure: Bleeding outcomes
timeFrame: While the infant is thrombocytopenic
measure: Compliance with transfusion guidelines
timeFrame: During NICU hospitalization
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Wilmington
country: United States
facility: A.I. duPont Hospital for Children
state: Delaware
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Christiana Care Health Services
name: Jody L Zisk, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Care Health Systems
name: David A Paul, MD
role: PRINCIPAL_INVESTIGATOR
References: