louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04144985: Comfort Comparison of Intravitreal Injection Eyelid Retraction Techniques
Official title: Eyelid Retraction Discomfort With Cotton Tipped Applicator, Unimanual and Speculum Intravitreal Injection Techniques: Eyelid Retraction Technique Randomized Comparison Trial (Eyelid RETRACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravitreal Injection
Pain
Keywords: Discomfort
Visual Analog Scale
Speculum
Eyelid retraction
Cotton tipped applicator
Eyelid Speculum
Unimanual eyelid retraction
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated the discomfort associated with eyelid retraction during intravitreal injections. Participants had eyelid retraction with one of three methods: eyelid speculum, unimanual eyelid retraction method or with a cotton tipped applicator eyelid retraction technique. All participants were given a pain survey immediately after the injection to evaluate their discomfort level.

Detailed description: Comfort is an important factor in compliance and satisfaction during medical care With the millions of intravitreal injections done each year, even small improvements in participants' experiences could lead to significant benefit. During the process eye injections, the method of eyelid retraction has been shown to be one of the most significant sources of discomfort.

Many ophthalmologists use an eyelid speculum to retract the eyelids, but potentially more comfortable methods exist. The purpose of our study was to test the comfort eyelid retraction with an eyelid speculum to that of the unimanual eyelid retraction method and a cotton tipped applicator eyelid retraction technique.

Eligibility criteria: Inclusion Criteria:

* Adult participants receiving an intravitreal injection

Exclusion Criteria:

* iodine allergy
* prior ocular surgery other than uncomplicated cataract surgery

Primary outcomes:
measure: Pain Associated with Different Eyelid Retraction Technique
timeFrame: 1 minute
Secondary outcomes:
measure: Difference in Pain in Treatment Naive Participants
timeFrame: 1 minute
measure: Associations of Hemoglobin A1c and Ocular Pain
timeFrame: 1 minute
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
Study officials:
affiliation: Kings County Hospital Department of Emergency Medicine
name: Joseph J Raevis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03558685: Weight Loss Diet in Obesity With Metabolic Syndrome
Official title: Weight Loss Diet in the Treatment of Obese Patients With the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Diet Modification
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Concomitant interventions included lifestyle modification with a personally tailored program of diet as detailed below and physical activity adjusted for age and specific physical limitations, targeting engagement in physical activity of at least 150 minutes/week. Lipid lowering and or blood pressure lowering drugs were prescribed as needed according to guideline-assisted medical practice. Patients were seen by a physician every 3 month. The dietitian had a weekly meeting with the patients for the first three months, every other week during months 4-6, once a month during month 7-9 and every 6 weeks during the last three months of the study.


Eligibility criteria: Inclusion Criteria:

- fulfilled the diagnostic criteria for the metabolic syndrome as defined by the Third Report of the Adult Treatment Panel (ATPIII).

Exclusion Criteria:

* diabetes
* the presence of current or recent pregnancy or intention to conceive within the trial's period
* chronic renal or liver disease
* past bariatric surgery
* current participation in any dietary/ medical program with current continuous weight loss.

Primary outcomes:
measure: % BMI Change
timeFrame: One Year, from the initiation of the intervention to its termination.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Endocrinology, Metabolism and Hypertension Tel Aviv-Sourasky Medical Center
name: Naftali Stern, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01304485: PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Official title: Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Recurrent Prostate Carcinoma
sodium acetate c11
PET
prostate cancer
rising PSA
PSA recurrence
biochemical recurrence
Lead sponsor: Phoenix Molecular Imaging
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

Detailed description: The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.

A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.

The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.

Specific questions to be addressed:

1. What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?
3. What is the optimal imaging protocol in terms of imaging time after injection?

Eligibility criteria: Inclusion Criteria:

* recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

Exclusion Criteria:

* \< 18 years old
* claustrophobic patients

Primary outcomes:
measure: SUV (Standardized Uptake Value)
timeFrame: Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration
Secondary outcomes:
measure: PSA (prostate specific antigen)
timeFrame: Every 3 - 6 months for 24 months after PET imaging
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Molecular Imaging
state: Arizona
Study officials:
affiliation: Medical Director, Phoenix Molecular Imaging
name: Fabio Almeida, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00212485: Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
Official title: Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inherited Bleeding Disorders
Keywords: Hemophilia
Factor Deficiency
synovitis
sonogram
Lead sponsor: New York Presbyterian Hospital
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2005-09-21
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see whether power Doppler sonography (PDS) can be used to diagnose synovitis in patients with inherited bleeding disorders.

Detailed description: Aim #1 - To determine if PDS can be used to diagnose synovial hypertrophy and inflammation in joint disease associated with inherited bleeding disorders. MRI will be used as a reference standard.

Aim #2 - To determine if PDS can be used to assess therapeutic response to treatment.

Aim #3 - To determine if PDS can be used as a screening tool for diagnosing early synovitis.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of inherited bleeding disorder

For Aim 1:

* Age of at least 6 years
* History of at least 4 bleeds in the same joint in the preceding 6 months
* Joint swelling, synovitis or deformity

For Aim 2:

* Meet inclusion criteria for Aim 1 and will be having a synovectomy

For Aim 3:

* Age of at least 1 year
* Have had at least 2 joint bleeds

Exclusion Criteria:

* Not meeting inclusion criteria

Primary outcomes:
measure: Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint
timeFrame: Up to 1 month
measure: Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention
timeFrame: 1. day of synovectomy; 2. 6 months post synovectomy.
measure: Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Hospital for Special Surgery
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Suchitra S Acharya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757185: Compromised Microcirculation in Women With Polycystic Ovary Syndrome
Official title: Compromised Microcirculation in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Polycystic Ovary Syndrome
Keywords: skin blood flow
microcirculation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-09-23
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS.

Detailed description: In these studies, we propose to use the skin as a relatively non-invasive model to examine cardiovascular and endothelial function in obese women with and without PCOS. Data have indicated an important role for testosterone in influencing the peripheral microcirculation. While testosterone can lead to vasodilation in the peripheral microcirculation in both men and in women without PCOS, testosterone appears to induce vasoconstriction in women with PCOS. The differential response between women with and without PCOS, and between men and women may be the result of differential ET-1 actions in the vessel, and regulated by the receptor subtype is involved in these actions.

Eligibility criteria: Inclusion Criteria:

* Obese women (18-35) years with and without PCOS

Exclusion Criteria:

* Conditions that would preclude safe use of hormones

Primary outcomes:
measure: Skin blood flow and cutaneous vascular conductance
timeFrame: 6 non consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: John B. Pierce Laboratory
state: Connecticut
Study officials:
affiliation: John B. Pierce Laboratory
name: Nina Stachenfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01303185: Pulsed Dye Laser for the Psoriatic Nail
Official title: Pulsed Dye Laser for the Psoriatic Nail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Nail
Keywords: Psoriatic Nail
Pulsed dye laser
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psoriatic nail patients

Brief summary: The treatment options for nail psoriasis have been limited, and the management of nail psoriasis has been challenging for physicians.To evaluate the effect of pulsed dye laser (PDL) in the treatment of nail psoriasis.

Detailed description: Psoriatic nails of patient's right hand were treated using PDL (595 nm) .The pulsed duration is 1.5ms, the beam diameter is 7mm, and the laser energy is 8.0 to 10.0 J/cm2. The treatment course of pulse dye laser is once monthly for 6 months. Psoriatic nails of both hands are treated with Tazarotene cream for 6 months. Clinical efficacy is statistically evaluated according to Nail Psoriasis Severity Index (NAPSI) score differences between right and left hand one month after 3rd and 6th therapy.

Eligibility criteria: Inclusion Criteria:

* Psoriatic nail refractory to other topical and systemic treatment therapy
* ≧ 16 years old

Exclusion Criteria:

* Patient with pregnancy
* Patient with photo sensitivity
* Patient with severe wound around finger nails or paronychia
* Patient with hypersensitivity to Tazarotene cream

Primary outcomes:
measure: NAPSI
timeFrame: 3rd and 6th months
measure: global physician assessment
timeFrame: 3rd and 6th months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Ying-Yi Chiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01040585: Cost Effectiveness Of Linezolid In Central America
Official title: Cost Effectiveness Of Linezolid Vs Vancomycin In The Treatment Of Ventilator Acquired Pneumonia In Central America
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ventilator Acquired Pneumonia
Keywords: cost effectiveness
linezolid
ventilator acquired pneumonia
central america
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-29
Enrollment: 0
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: Adult men and women with VAP.

Brief summary: The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN) for the treatment of nosocomial Pneumonia associate to ventilator (VAP).


Eligibility criteria: Inclusion Criteria:

* Evidence of a legally acceptable representative signed and dated informed consent document indicating that him or her has been informed of all pertinent aspects of the study.
* Adult (18 years old or older) men and women with confirm diagnosis of VAP treated on ICU with LIN or VAN; on the selected institutions.

Exclusion Criteria:

* Adult men or women with nosocomial pneumonia not associated to a ventilator.

Primary outcomes:
measure: The rate of resistance Empirical treatment days before specific therapy. Treatment days with Linezolid. Treatment days with Vancomycin.
timeFrame: 4 months
measure: Rate of renal failure.
timeFrame: 4 months
measure: Rate of healing with Linezolid.
timeFrame: 4 months
measure: Rate of healing with Vancomycin.
timeFrame: 4 months
Secondary outcomes:
measure: Hospitalization days average with VAN and Linezolid.
timeFrame: 4 months
measure: Variation of prices and values among the different institutions.
timeFrame: 4 months
measure: The average costs of each intervention.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01463085: Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure
Official title: A Randomized, Controlled, Trial to Assess the Effects of Low-fat Dairy Intake on Endothelial Function and Blood Pressure in Subjects With Pre-hypertension or Stage 1 Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Dairy Research Institute
Sponsor class: OTHER
Collaborators: name: BioFortis
name: Provident Clinical Research
First posted: 2011-11-01
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.


Eligibility criteria: Inclusion Criteria:

* Subject is a female or male, 20-69 years of age, inclusive.
* Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
* Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
* Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
* Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
* Subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.

Exclusion Criteria:

* Subject has known coronary heart disease (CHD) or a CHD risk equivalent
* Subject has a history of any major trauma or major surgical event
* Subject has digital deformities that would prevent EndoPAT measurements.
* Subject has used medications known to alter body weight
* Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function
* Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low carbohydrate).

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 5 weeks
Secondary outcomes:
measure: Vascular function
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Glen Ellyn
country: United States
facility: Biofortis - Provident Clinical Research
state: Illinois
Study officials:
affiliation: Biofortis - Provident Clinical Research
name: Kevin C Maki, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04705285: Erb:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence
Official title: Erbium:Yag Laser Versus Pelvic Floor Training for the Treatment of Women With Mild to Moderate Stress Urinary Incontinence: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence.

Detailed description: This pilot study attempts to demonstrated the feasibility and security to run a randomized controlled study that compared the effectivity of erbium:yag laser used vaginally versus pelvic floor training, coached by a physiotherapist expert in pelvic floor disorders.

Patients are going to be randomized to pelvic floor exercises (10 sessions) or erbium:yag laser (2 sessions), and assess the results at 6 and 12 moths later on.

Eligibility criteria: Inclusion Criteria:

* Mild to Moderated Stress Urinary Incontinence

Exclusion Criteria:

* Mixed Urinary incontinence
* Pelvic organ prolase greater than stage 2
* Previous surgery for stress urinary incontinence and/or pelvic organ prolapse
* Severe Stress urinary incontinence

Primary outcomes:
measure: Change in quality of life
timeFrame: The questionnaire will be applied at baseline, 6 month and 1 year
Secondary outcomes:
measure: Pad test
timeFrame: at baseline, 6 month and 1 year
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico de La Florida
Study officials:
References:
Clinical trial NCT04124185: Natural History Study for Achromatopsia
Official title: Phenotyping and Genotyping Patients With Achromatopsia in Preparation for Gene Therapy Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achromatopsia
Keywords: Achromatopsia
CNGB3
CNGA3
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 85
Sex: ALL
Minimum age (years): 3
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Achromatopsia

Brief summary: In preparation for human clinical trials we intend to undertake a detailed phenotypic study to help to identify patients who may be suitable for therapeutic intervention. In addition, with the recent availability of advanced imaging modalities, further detailed phenotypic investigations will also be valuable in helping to probe the relationship between structure and function and may shed light on disease mechanisms.


Eligibility criteria: Inclusion Criteria:

* Patients with molecularly proven Achromatopsia or a typical clinical Achromatopsia phenotype with genetic screening pending.
* Minimum subject age of 3 years.
* Able to give consent/parent or guardian able to give consent.

Exclusion Criteria:

* Patients unable or unwilling to undertake consent or clinical testing.
* Patients unwilling to donate a blood sample in order to establish the genetic cause of their condition.

Primary outcomes:
measure: Complete ocular examination
timeFrame: 5 years
measure: Axial length
timeFrame: 5 years
measure: Corneal curvature
timeFrame: 5 years
measure: Optical Coherence Tomography
timeFrame: 5 years
measure: Visual acuity
timeFrame: 5 years
measure: Contrast sensitivity
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
References: