louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03453827: Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
Official title: Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Pseudoexfoliation Syndrome
Pseudophakia
Keywords: Pseudoexfoliation Syndrome
Cataract
Aberration
IOL decentration
IOL tilt
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent standard procedure cataract surgery with or without Pseudoexfoliation Syndrome.

Brief summary: To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.

Detailed description: 64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.

Eligibility criteria: Inclusion Criteria:

* patients 4-6 years after standard cataract surgery
* pseudoexfoliation Syndrome (PES)

Exclusion Criteria:

* Diabetic retinopathy
* Age related macula Degeneration
* retinal bloodvessel disease

Primary outcomes:
measure: IOL decentration
timeFrame: 4-6 years after cataract surgery
measure: IOL tilt
timeFrame: 4-6 years after cataract surgery
measure: IOL decentration
timeFrame: 4-6 years after cataract surgery
measure: IOL tilt
timeFrame: 4-6 years after cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05792527: L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis
Official title: The Use of L-carnitine in Modulating Pain and Inflammation in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating the possible efficacy and safety of L-carnitine in rheumatoid arthritis via targeting Jak/STAT pathway and TGF-β1


Eligibility criteria: Inclusion Criteria:

* Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (9) i.e., 28 joints disease activity score (DAS-28) \>2.6.
* Patients receive the conventional DMARDs
* Both sexes.
* Age range between 18 and 70 years old.

Exclusion Criteria:

* Patients with heart disease (congestive heart failure, arrhythmia, hypertension, ischemic heart diseases), diabetes, active infection, other illness except rheumatoid arthritis.
* Patients with renal and hepatic dysfunction.
* Patients receiving biological DMARDs.
* Patients receiving oral prednisolone greater than 15 mg/day.
* Patients with hypersensitivity to study medications.
* Patients using antioxidants.
* Pregnant and lactating females.

Primary outcomes:
measure: The change in DAS-28-CRP score
timeFrame: 3 months
measure: The change in Multidimensional Health Assessment Questionnaire (MDHAQ) score
timeFrame: 3 months
Secondary outcomes:
measure: The change in serum level of C-reactive protein (CRP)
timeFrame: 3 months
measure: The change in serum level of Signal transducer and activator of transcription 3(STAT 3).
timeFrame: 3 months
measure: The change in serum level of Transforming growth factor β1(TGF-β1).
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: Gharbia
Study officials:
References:
Clinical trial NCT01275027: A Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
Official title: A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Diabetes
Keywords: diabetes
blood sugar
insulin
nutritional supplement
nutraceutical
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 0
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: The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.

Detailed description: The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.

The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Men and women who are at least 18 years old
* Diagnosis of Type 2 Diabetes
* Has been on stable diabetes medication/insulin for the past three months

Exclusion Criteria:

* Women who are pregnant, breastfeeding or planning to become pregnant
* Diagnosis of Celiac Disease or gluten intolerance
* Current or active kidney disease
* Current or active liver disease
* Any food allergies

Primary outcomes:
measure: Blood Sugar
timeFrame: 16 weeks
measure: HgA1c reduction
timeFrame: 16 weeks
Secondary outcomes:
measure: Diabetes medication
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
Study officials:
affiliation: Avera McKennan Hospital & University Health Center
name: Edward Zawada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372827: Study of Brinzolamide and Timolol When Added to Travoprost in Primary Open-angle Glaucoma or Ocular Hypertension
Official title: Efficacy and Safety of Timolol Maleate 0.5% Compared to Brinzolamide 1% When Added to Travoprost 0.004% in Primary Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Pigment Dispersion Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 245
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: The purpose of the study is to compare the efficacy and safety of Timolol 0.5% solution to Brinzolamide 1% each given twice daily when added to Travoprost 0.004% given each evening.


Eligibility criteria: Inclusion Criteria:

* Patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmHg at 08:00 hours.

Exclusion Criteria:

* Under 18 years

Primary outcomes:
measure: Mean diurnal intraocular pressure at month 3
Secondary outcomes:
measure: Individual intraocular pressures measured at 08:00, 12:00 and 16:00 at month 3.
measure: Reduction from baseline in mean diurnal intraocular pressure and individual timepoints.
measure: Visual acuity, Slit lamp biomicroscopy and adverse events during 3 months.
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Mainz Site
Study officials:
affiliation: Study Manager
name: Anna Grau
role: STUDY_DIRECTOR
References:
citation: Hollo G, Chiselita D, Petkova N, Cvenkel B, Liehneova I, Izgi B, Berta A, Szaflik J, Turacli E, Stewart WC. The efficacy and safety of timolol maleate versus brinzolamide each given twice daily added to travoprost in patients with ocular hypertension or primary open-angle glaucoma. Eur J Ophthalmol. 2006 Nov-Dec;16(6):816-23. doi: 10.1177/112067210601600606.
Clinical trial NCT01187927: Drug Use Investigation for Cervarix®
Official title: Drug Use Investigation for Cervarix®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Papillomavirus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 1230
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese women who received Cervarix® for the first time

Brief summary: This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.


Eligibility criteria: Inclusion Criteria:

* Subject must be female
* Subject must be aged 10 and over

Exclusion Criteria:

* Subject with obvious fever
* Subject with obvious severe acute disease
* Subject with hypersensitivity to any component of Cervarix®
* Other than above, subject who is in inappropriate conditions for vaccination

Primary outcomes:
measure: The number of subjects with solicited local adverse events
timeFrame: 7 days after vaccination
measure: The number of subjects with solicited general adverse events
timeFrame: 7 days after vaccination
measure: The number of subjects with unsolicited adverse events
timeFrame: 30 days after vaccination
measure: The number of subjects with serious adverse events
timeFrame: 30 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06391827: A Study to Evaluate Safety, Tolerability, and PK of DA-7503 in Healthy Adult and Elderly Participants
Official title: A Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Orally Administered DA-7503 After Single and Multiple Ascending Dose Regimens in Healthy Adult and Elderly Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, placebo-controlled, randomized, phase 1 study to evaluate safety, tolerability, and pharmacokinetics of orally administered DA-7503 after single and multiple ascending dose regimens in healthy adult and elderly participants


Eligibility criteria: Inclusion Criteria:

1. Healthy volunteers(Age: 19\~55 years, 65\~85 years)
2. Body weight≥50.0kg, 18.0kg/m²≤BMI≤30.0kg/m²

Exclusion Criteria:

1. Clinically significant Medical History
2. Allergy or Drug hypersensitivity
3. AST, ALT, Total billurbin \> Upper Normal Range\*1.5, eGFR\<60mL/min/1.73m²
4. Positive for serum test results(hepatitis B, hepatitis C, HIV, syphilis test)
5. Heavy smoker(more than 10 cigarettes/day)
6. Heavy caffeine intake(more than 5 units/day)
7. Heavy alcohol intake(more than 210g/week)

Primary outcomes:
measure: Pharmacokinetics of DA-7503 single dose oral administration
timeFrame: 5 days
measure: Pharmacokinetics of DA-7503 single dose oral administration
timeFrame: 5 days
measure: Pharmacokinetics of DA-7503 multiple dose oral administration
timeFrame: 11 days
measure: Pharmacokinetics of DA-7503 multiple dose oral administration
timeFrame: 11 days
measure: Pharmacokinetics of DA-7503 multiple dose oral administration
timeFrame: 11 days
measure: Pharmacokinetics of DA-7503 multiple dose oral administration
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03184727: Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
Official title: Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Pulmonary Vascular Disorder
Right Ventricular Dysfunction
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stable COPD patients

Brief summary: The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days. Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD. Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance. What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied. The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.


Eligibility criteria: Inclusion Criteria:

* stable COPD patients

Exclusion Criteria:

* patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;
* psychopath, addict or patients not able to coordinate;
* patients in pregnancy or breastfeeding;
* patients with limited life expectancy;
* patients with contraindiction for MRI or PET;
* patients having cerebrovascular events in 3 months;
* unstable COPD patients

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 years
Secondary outcomes:
measure: COPD exacerbations
timeFrame: 3 year
measure: GOLD degree
timeFrame: 3 year
measure: NYHA degree
timeFrame: 3 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fu Wai Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01178827: Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.


Eligibility criteria: Inclusion Criteria:

* Patient presents symptoms of overactive bladder
* Patient has age associated memory impairment
* No acute or unstable medical conditions

Exclusion Criteria:

* History of alcohol or substance abuse within 1 year prior to study
* Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
* Has known bleeding disorder (hemophilia)
* Previous abdominal bypass surgery for obesity

Primary outcomes:
measure: Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
timeFrame: Day 10 Post-Dose
measure: Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
timeFrame: Day 2 Post-Dose
Secondary outcomes:
measure: Plasma Levels of Sanctura XR® at Day 10 Post-dose
timeFrame: Day 10 Post-Dose
measure: Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
timeFrame: Day 2 Post-Dose
measure: Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
timeFrame: Baseline, 10 Days
measure: Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
timeFrame: Baseline, 10 Days
measure: Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
timeFrame: Baseline, 10 Days
measure: Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
timeFrame: Baseline, 10 Days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02963727: Use of Wharton Jelly Derived Mesenchymal Stem Cells for Knee Osteoarthrosis
Official title: Knee Osteoarthrosis (KOA) in Jordanian Patients: a Phase I Dose-finding Study Using Wharton Jelly Derived Mesenchymal Stem Cells (WJMSC) for Advanced Stage III and IV KOA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Knee Osteoarthrosis
Keywords: osteoarthrosis
Knee
Wharton Jelly
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 10
Sex: ALL
Minimum age (years): 42
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Wharton Jelly derived Mesenchymal Stem Cells (WJMSC) will be injected in patients diagnosed with Knee osteoarthrosis

Detailed description: Ten patients from both genders diagnosed with Knee osteoarthrosis, will be enrolled according to strict inclusion and exclusion criteria. These patients will be injected with Wharton Jelly derived Mesenchymal Stem Cells. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee.

Eligibility criteria: Inclusion Criteria:

* Severe KOA stage III or IV by Laurance \& Kellgren staging as judged by Posterioranterior (PA) Xray of the knee joint.
* Willing to participate by signing the informed consent

Exclusion Criteria:

1. Sublaxation beyond 20 degrees of the bones of the knee joint
2. Oral anticoagulants or heparin therapy
3. Heart failure or arrhythmia
4. Body Mass Index \> 35
5. Uncontrolled Diabetes Mellitus.
6. Evidence of Infectious Diseases.
7. Active infection
8. Malignancy
9. Pregnancy
10. Anemia less than 11g/dl or thrombocytopenia less than 100,000 or leucopenia less than 3000.
11. Unreliable patients
12. Non-resident in Jordan

Primary outcomes:
measure: Evaluation of the safety and tolerability of the intra articular injection
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the efficacy of intra-articular injection of WJMSC
timeFrame: 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00895427: A Study Comparing Skin Fluorescence to Coronary Artery Calcification
Official title: A Cross-Sectional Study Comparing Noninvasive Skin Fluorescence to Coronary Artery Calcification Measured by Rapid Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Coronary Artery Calcification
Keywords: Coronary artery calcification
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
Collaborators: name: New Mexico Heart Institute, PA
First posted: 2009-05-08
Enrollment: 240
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects are sorted into the follwoing categories for age (years): men:45-54,55-64,65+, women: 50-59, 60-69, 70+. In addition, subjects will be sorted into the follwoing categories for CACS:0-10, 11-100, 101-400, 401-1000, \>1000 and absence/presence of diagnosed diabetes (type 1 or type 2)

Brief summary: This study examines the relationship between the SCOUT DM device and coronary artery calcification as determined by rapid computed tomography in patients at risk for coronary heart disease.

Detailed description: This is a cross-sectional, single site, cohort screening trial. The correlation between the measured skin fluorescence and the CACS will be determined using a design that includes stratification by gender, subject age and subject CAC score. This design requires a single patient visit to the clinical site and a single measurement on the SCOUT device.

Eligibility criteria: Inclusion Criteria:

* Males ≥ 45 years or females ≥ 50 years old that have had a coronary artery calcification score determined by rapid computed tomography at the clinical site within the last six months.

Exclusion Criteria:

* Receiving investigational treatments
* Psychosocial issues that interfere with an ability to follow study procedures
* Known to be pregnant
* Receiving dialysis or having known renal compromise
* Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Recent or current oral steroid therapy or topical steroids applied to the left forearm
* Current chemotherapy, or chemotherapy within the past 12 months
* Receiving medications that fluoresce\*
* Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
Study officials:
affiliation: VeraLight, Inc.
name: John Maynard, MS
role: STUDY_DIRECTOR
References: