louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01716507: 23 Gauge and 20 Gauge Vitrectomy for Rhegmatogenous Retinal Detachments
Official title: A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Keywords: RRD
Rhegmatogenous
Retinal
Detachment
PPV
Pars Plana Vitrectomy
Gauge
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.

Detailed description: The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation. Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal preference.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written consent and comply with study assessments for the full duration of the study.
* Presence of retinal detachment with history of cataract surgery.
* Vision of hand motion or better.

Exclusion Criteria:

* Presence of a very large tear or type of retinal detachment usually a result of trauma.
* Prior eye surgery except for cataract surgery.
* Presence of significant scar tissue.
* Presence of retinal detachment due to hole in the macula.

Primary outcomes:
measure: Assess the initial retinal reattachment rates by comparing the percentages/amount.
timeFrame: 1 Year
Secondary outcomes:
measure: Change in best-corrected visual acuity by comparing letters read.
timeFrame: 6 months
measure: Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.
timeFrame: 1 year
measure: Operating time for 23 gauge versus 20 gauge PPV (time measurement)
timeFrame: 1 day- Day of surgery
Other outcomes:
measure: Compare rates of intraoperative and postoperative complications by comparing the amount and severity of these complications.
timeFrame: 1 year
Locations:
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
Study officials:
affiliation: Wills Eye
name: Jason Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036307: Supplementation With Omega-3: Mechanism of Action
Official title: Supplementation With Omega-3: Mechanism of Action
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Keywords: Fish oils
Triglycerides
Blood pressure
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a trial of two marketed fish oil supplements, one with a high EPA:DHA ratio and the other with a high DHA:EPA ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.

Detailed description: Observational studies have shown that fish consumption is associated with a lower risk of cardiovascular disease, and clinical trials have demonstrated that fish oil nutritional supplementation is associated with improvement in cardiometabolic risk factor profiles including fasting triglycerides and blood pressure. However, the mechanisms of action of fish oils are not well understood. Specifically, the effects of different compositions in terms of the ratio of the fatty acids EPA and DHA are not known. We are proposing a pilot and feasibility study of fish oil nutritional supplementation in 40 healthy adult participants with two different commercially available fish oil (high EPA/DHA ratio, high DHA/EPA ratio, sample of 20 per group) with the hypothesis that 4 weeks of supplementation with fish oil results in differential changes in platelet function, blood pressure and fasting triglyceride levels . We will also bank blood and urine for future mechanistic studies. This pilot study will allow us to collect preliminary data for definitive mechanistic studies of the effects of fish oil supplementation and to demonstrate the feasibility of this protocol.

Eligibility criteria: Inclusion Criteria:

* Healthy adults 20-75 years of age.
* Participant of the Principal Investigator's prior studies studies who have agreed to be contacted for future studies.

Exclusion Criteria:

* Current user of fish oil supplements
* Current user of statins
* Allergy to fish or seafood products
* Diagnosed/treated diabetes mellitus
* Using aspirin or NSAIDS or other "blood-thinning medication"

Primary outcomes:
measure: Fasting triglyceride level
timeFrame: 4 weeks
Secondary outcomes:
measure: Seated blood pressure
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Dhananjay Vaidya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06629207: Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder
Official title: Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
REM Sleep Behavior Disorder
Dementia, Lewy Body
Keywords: Parkinson Disease
Artificial Intelligence
REM Sleep Behavior Disorder
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to systematically document the course of REM sleep behavior disorder (RBD) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. Participants will be clinically evaluated and 2 imaging procedures will be done.


Eligibility criteria: Inclusion Criteria:

1. Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
2. Written informed consent

Exclusion Criteria:

1. Known diagnosis of PD or other neurodegenerative disorder
2. Unequivocal signs of parkinsonism on examination
3. Narcolepsy or other known causes of RBD
4. Moderate to severe obstructive sleep apnea
5. Abnormal neurological or MRI examination

Primary outcomes:
measure: Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection
timeFrame: From enrollment to end of follow-up period, expected to be 48 months
Secondary outcomes:
measure: Comparison of the Estimated versus Observed Annual Conversion Risk of Isolated Rapid Eye Movement Behavior Disorder (iRBD) to Neurodegenerative Disorders
timeFrame: From enrollment to end of follow-up period, expected to be 48 months
measure: Evaluation of Deep Learning Model Accuracy in Predicting Conversion of Isolated REM Sleep Behavior Disorder (iRBD) to Parkinson's Disease
timeFrame: From enrollment to end of follow-up period, expected to be 48 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Clinic for Nuclear Medicine
Study officials:
affiliation: University Bern, Inselspital, Center for Artificial Intelligence in Medicine
name: Kuanggyu Shi, Prof. Dr. ing.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03130907: The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
Official title: The Role of Ureteral Stenting Following Uncomplicated Ureteroscopy for Ureteral and Renal Stones: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteroscopy
Lead sponsor: San Antonio Uniformed Services Health Education Consortium
Sponsor class: FED
First posted: 2017-04-27
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is well established that uncomplicated distal ureteroscopy can be safely performed without leaving a ureteral stent. However, many urologists continue to leave ureteral stents following uncomplicated ureteroscopy, regardless of stone location, due to concerns for post-operative complications, patient symptoms and to reduce unplanned medical visits. There is a paucity of data regarding the utility of stent placement for proximal ureteral or renal stones following ureteroscopy. We have designed a prospective, randomized controlled trial to evaluate the role of ureteral stent placement following ureteroscopy and pyeloscopy in proximal and renal stones.


Eligibility criteria: Inclusion Criteria:

* Adult patients age ranges 18-89 with solitary or multiple proximal ureteral or renal stones 1.5cm or smaller measured in the longest dimension on preoperative imaging (CT or xray). Proximal ureteral stones are those proximal to the pelvic brim in the ureter.

Exclusion Criteria:

* Stone size greater than 1.5 cm on preoperative imaging
* Pregnancy
* Stent placement prior to ureteroscopy ("pre-stented patients")
* Patients with solitary kidney

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Subjective patient symptom scores
timeFrame: 6 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: BAMC
state: Texas
Study officials:
References:
Clinical trial NCT00759707: Endothelial Function in Lower Extremity Bypass Grafts
Official title: Endothelial Function in Lower Extremity Bypass Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: saphenous vein bypass grafts
flow-mediated vasodilation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 19
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 determine whether or not saphenous vein \[arterial\] bypass grafts in the leg relax in response to increases in blood flow.

Detailed description: Subjects who have undergone saphenous vein \[arterial\] bypass grafts from the femoral to above-knee popliteal artery will undergo ultrasound imaging at rest, and again after 5 minutes of blood pressure cuff occlusion of the calf. (at 1 minute and 15 minutes) Subjects will then be given sub-lingual nitroglycerin, and repeat ultrasound will be performed 3 minutes later. Following 10 minutes of rest, subjects will be given intravenous L-NMMA, a specific nitric oxide inhibitor, to help determine the responsible agent of the vein graft flow mediated dilation.

Eligibility criteria: Inclusion Criteria:

* Adults who have undergone femoral artery to above-knee popliteal artery saphenous vein bypass grafts

Exclusion Criteria:

* Amputation beyond the toes
* Critical limb ischemia defined as rest pain, non-healing ulceration or gangrene
* Pregnancy

Primary outcomes:
measure: Change From Baseline in Saphenous Vein Bypass Graft Vasodilation
timeFrame: Single visit study
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Joshua A. Beckman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01993407: Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Official title: Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Brain Injuries, Traumatic
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: New Jersey Commission on Brain Injury Research
First posted: 2013-11-25
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.


Eligibility criteria: Inclusion Criteria:

* If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage.
* If you are between the ages of 19 and 65.

Exclusion Criteria:

For participants with Traumatic Brain Injury:

* If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor).
* If your Brain injury is less than 6 months ago.

For healthy participants:

-If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor).

For All participants:

* If you have significant psychiatric history (such as schizophrenia or bipolar disorder.)
* If you have a alcohol or drug abuse history.
* If you are currently taking certain types of medications, which the study doctor will review.
* If you do not have a working knowledge of the English Language.

Primary outcomes:
measure: Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation Research Center
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Starla Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05886907: Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Official title: Assessing the Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Presbyopia
Astigmatism
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will wear the products (test and comparator) in a predetermined order.
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to assess on-eye performance and overall fit of an investigational multifocal toric contact lens to aid in confirmation of the study lens design.

Detailed description: Subjects will attend 3 study visits with a planned individual duration of participation of up to 10 days.

Eligibility criteria: Key Inclusion Criteria:

* Requires ADD (additional power for near vision);
* Currently wears multifocal soft contact lenses in both eyes during the past 3 months;
* Manifest cylinder power between -0.75 diopter (D) and -1.00 D;
* Best Corrected Visual Acuity (BCVA) of logMAR 0.10 (Snellen 20/25) or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Monovision contact lens wear.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Distance Visual Acuity (VA) With Study Lenses
timeFrame: Day 2, each wear period. A wear period was approximately 2 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Johns Creek
country: United States
facility: Johns Creek Research Clinic
state: Georgia
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT01084707: Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
Official title: Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Detailed description: This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility criteria: Inclusion Criteria:

* Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
* Prior regular use of nicotine mouth spray

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: During the last dosing interval (hour 11-12 post-dose)
measure: Average Concentration
timeFrame: During the last dosing interval (hour 11-12 post-dose)
Secondary outcomes:
measure: Time of Maximum Concentration
timeFrame: During the last dosing interval (hour 11-12 post-dose)
measure: Minimum Plasma Concentration
timeFrame: During the last dosing interval (hour 11-12 post-dose)
measure: Peak-Trough Fluctuation
timeFrame: During the last dosing interval (hour 11-12 post-dose)
measure: Nicotine Plasma Concentration
timeFrame: One hour after start of treatment
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Pharmacology
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06312007: Semi-seated Holding Position to Reduce Stress Responses in in the Neonatal Intensive Care Unit
Official title: Semi-seated Holding Position to Reduce Stress Responses in Spontaneous Crying Newborn in the Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Semi Seated Position
Side Lying Position
Keywords: semi seated position, cortisol saliva, oxytocin saliva
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 45
Sex: ALL
Minimum age (years): 32
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention semi seated position Control side lying position
Primary purpose: OTHER

Brief summary: This study to compare half semi seated position and side lying position with cortisol level on the neonate's stress respon

Detailed description: This study was a randomized control trial with inclusion criteria of moderately preterm, late preterm, and term baby. Exclusion criteria were babies experiencing respiratory distress and multiple congenital anomalies. Two treatments were carried out, the first was in a semi-seated position, the second was the control group, given the side lying position, then the levels of cortisol and salivary oxytocin were compared to see the stress response.

Eligibility criteria: Inclusion Criteria:

* Modertely preterm, late preterm, aterm

Exclusion Criteria:

* neonates with respiratory distress
* multiple congenital anomali

Primary outcomes:
measure: Kortisol level
timeFrame: 20 weeks
measure: Oxytocin level
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Hasanuddin University
state: South Sulawesi
Study officials:
References: