louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01934842: A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
Official title: A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Anemia
Lead sponsor: Seventh Sense Biosystems
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare blood collection from the forearm using an investigational device, TAP20-C to blood collection from the finger tip. The blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.


Eligibility criteria: Inclusion Criteria:

Healthy Subject Group

1. Male and female volunteers 18 years of age or older.
2. Voluntary written consent to participate in this study.

Diabetic Subject Group

1. Male and female volunteers 18 years of age or older.
2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.
3. Voluntary written consent to participate in this study.

Exclusion Criteria:

1. Subjects who are pregnant or nursing mothers by self-report.
2. Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins.
3. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
4. Subjects with a missing index or middle finger on either hand or a missing forearm
5. Subjects who have known allergies to titanium.

Primary outcomes:
measure: Non Inferiority of Analyte Levels
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Seventh Sense Biosytems
state: Massachusetts
Study officials:
References:
Clinical trial NCT06469242: Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Official title: Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: Multifocal
Myopia
Hyperopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 104
Sex: ALL
Minimum age (years): 40
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 evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.

Detailed description: Subjects will be expected to attend 7 office visits for an individual duration of participation of 28 to 40 days.

Eligibility criteria: Key Inclusion Criteria:

* Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
* Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
* Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Currently pregnant or lactating.
* History of amblyopia, strabismus, or binocular vision abnormalities.
* Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
* Monovision contact lens wearers and wearers of contact lens in one eye only.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Binocular visual acuity at distance (4 meters) at Week 1
timeFrame: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period is 14 days (-0/+2 days) according to randomization assignment.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kurata Eyecare Center
state: California
city: Oakland
country: United States
facility: Elsa Pao, OD
state: California
city: Maitland
country: United States
facility: Drs. Giedd, P.A.
state: Florida
city: Orlando
country: United States
facility: Vision Health Institute
state: Florida
city: Medina
country: United States
facility: Wesley Optometric Consulting
state: Minnesota
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
state: Ohio
city: Powell
country: United States
facility: Insight Research Clinic LLC
state: Ohio
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT00689442: Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels
Official title: A 4-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of JTT-705 600 mg Versus Placebo Administered Once Daily in Combination With Atorvastatin 20 mg in Patients With Low HDL Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 105
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: The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with low HDL


Eligibility criteria: Inclusion Criteria:

* Patients having lipid values as indicated below:
* HDL-C ≤ 1.0 mmol/L (40 mg/dL)
* TG ≤4.5 mmol/L (400 mg/dL)
* Patients with CHD or CHD risk equivalent
* Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index of ≥ 35 kg/m2
* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
* Concomitant use of medications identified in the protocol

Primary outcomes:
measure: % change from baseline in HDL-C; inhibition of CETP activity
timeFrame: 4-weeks
Secondary outcomes:
measure: % change from baseline in LDL-C and TC/HDL-C
timeFrame: 4-weeks
measure: Plasma concentration of JTT-705
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
Study officials:
References:
Clinical trial NCT04615442: ECV - Epihunter Clinical Validation
Official title: ECV - Epihunter Clinical Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absence Seizures
Absence Epilepsy
Lead sponsor: Epihunter NV
Sponsor class: INDUSTRY
Collaborators: name: Filadelfia Epilepsy Hospital
name: KU Leuven
name: Boston Children's Hospital
name: Institute of Neurology and Neuropsychology, Tbilisi, Georgia
First posted: 2020-11-04
Enrollment: 102
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.


Eligibility criteria: Inclusion Criteria:

* Subjects should have an indication of having absence seizures
* Subjects should be admitted for video EEG monitoring as part of their clinical practice
* Age \> 4 years

Exclusion Criteria:

* Head circumference should be compatible for wearable EEG device (40-70cm)
* The subject should be able to understand instructions and refrain from removing the device from its head

Primary outcomes:
measure: Sensitivity for electrographic seizures of study device compared to video EEG
timeFrame: 9 months
measure: Number of false alarms by study device per hour
timeFrame: 9 months
Secondary outcomes:
measure: Feasibility testing of automated behavioral testing triggered by automated detection
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Leuven
country: Belgium
facility: UZ Leuven
city: Dianalund
country: Denmark
facility: Danish Epilepsy Center
city: Tbilisi
country: Georgia
facility: Institute of Neurology and Neuropsychology
Study officials:
affiliation: Epihunter NV
name: Dirk Loeckx, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00967642: Intravenous Insulin in Patients With Diabetes After Percutaneous Coronary Intervention (PCI)
Official title: Intravenous Insulin for 24 Hours in Patients With Diabetes Mellitus Submitted to Percutaneous Coronary Intervention With Stent: Effects Upon Oxidative Stress and Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Percutaneous Coronary Intervention
Keywords: Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: FIPE
First posted: 2009-08-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients submitted to PCI with stent.


Eligibility criteria: Inclusion Criteria:

* Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal
* Age: 18-80 years old

Exclusion Criteria:

* Restenosis
* Drug elution stent
* Acute coronary syndrome at last 30 days
* Use anti inflammatory, antibiotic, vitamin E
* Inflammatory disease or oncologic

Primary outcomes:
measure: Reintervention, Myocardial Infarction, Cardiovascular Death
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06913842: Adrenal Myelolipomas Case Series
Official title: Adrenal Myelolipomas Case Series Laparoscopic Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Myelolipoma
Keywords: Adrenal, Incidentaloma, Myelolipoma, Laparoscopy.
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2025-04-06
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 Patients who underwent laparoscopic surgery.

Brief summary: Six cases (72 years old female patient, 63 years old male patient, 57 years old female patient, 61 years old female, 72 years old female and 56 years old female) of clinically and radiologically suspected cases of symptomatic adrenal myelolipoma are discussed here. All cases described, presented with flank pain radiating which was suspected as adrenal mass by Computed Tomography (CT) evaluation. All six cases were histopathologically confirmed as adrenal myelolipoma and managed by laparoscopic surgical excision.

Detailed description: The management in all cases was by laparoscopic adrenalectomy with transperitoneal approach. Several retrospective and comparative studies addressed the advantage of minimally invasive adrenalectomy specifically consistent in less postoperative pain, improved patients' satisfaction, shorter hospital stay and recovery time when compared to open adrenalectomy.

The laparoscopic transabdominal lateral adrenalectomy is currently the most widely used approach.

All our cases were managed by this technique. In our cases initial peritoneal access is achieved 2cm inferior to the right/left costal margin in the midclavicular line, a pressure of 15mmHg is used for CO2 insufflation. Optical access 10-12mm trocar for the endoscope is placed in the pararectal line 5cm above the umbilicus. Under direct vision, the second 10- 12 mm trocar is placed medially to the first one. The third trocar (5mm) is inserted 3 cm above the anterior superior iliac spine in the anterior axillary line. The fourth trocar (5mm) is inserted at the subcostal angle. The key factor for an adequate exposure is an effective dissection of the Toldt fascia. Vascular structures are ligated with Hem-O-Lock and subsequent dissection of the adrenal gland with ultrasonic energy. The adrenal is extracted through a Gibson-type incision, a Penrose drain was left in all cases with its removal upon discharge of the patient.

Eligibility criteria: Inclusion Criteria:

* Patients with adrenal myelolipoma

Exclusion Criteria:

* Patients without CT scan with myelolipoma

Primary outcomes:
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mérida
country: Mexico
facility: Mexican Social Security Institute: Regional General Hospital No. 1
state: Estado De Yucatán
Study officials:
References:
citation: Samimagham H, Kazemi Jahromi M. Bilateral Adrenal Myelolipoma, A Case Presentation and Brief Literature Review. Iran J Kidney Dis. 2020 Jan;14(1):62-64.
Clinical trial NCT02608242: PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin
Official title: A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22189 in Comparison to Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypertension
Hyperlipidemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 123
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Detailed description: This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
* Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

Primary outcomes:
measure: Telmisartan Cmax
timeFrame: 0 - 72 hrs
measure: Telmisartan AUClast
timeFrame: 0 - 72 hrs
measure: Amlodipine Cmax
timeFrame: 0 - 168 hrs
measure: Amlodipine AUClast
timeFrame: 0 - 168 hrs
measure: Rosuvastatin Cmax
timeFrame: 0 - 48 hrs
measure: Rosuvastatin AUClast
timeFrame: 0 - 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Chunju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
References:
Clinical trial NCT01726842: Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
Official title: Pediatric Vision Scanner for the Eradication of Amblyopia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Strabismus
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Retina Foundation of the Southwest
First posted: 2012-11-15
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children presenting for ophthalmic exam at eye clinic.

Brief summary: The purpose of this project is to compare the performance of the Pediatric Vision Scanner (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at detecting amblyopia and strabismus.


Eligibility criteria: Inclusion:

* 2-6 years old
* complete ophthalmic examination including cycloplegic refraction conducted on the same day or within 3 months
* strabismic, anisometropic, or normal (normal eye examination and refractive error according to AAPOS guidelines)
* parent provides informed consent

Exclusion:

* other ocular disease (includes media opacities, anomalous optic nerve, ptosis, lid hemangioma, conjunctivitis, blepharitis, symptomatic NLD) or systemic disease (JIA, JRA, neurofibromatosis)
* developmental delay
* strabismus surgery in the past 6 months

Primary outcomes:
measure: Binocularity score
timeFrame: Day 1
Secondary outcomes:
measure: Presence of amblyopia risk factors
timeFrame: Day 1
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
affiliation: Retina Foundation of the Southwest
name: Eileen Birch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loudon SE, Rook CA, Nassif DS, Piskun NV, Hunter DG. Rapid, high-accuracy detection of strabismus and amblyopia using the pediatric vision scanner. Invest Ophthalmol Vis Sci. 2011 Jul 7;52(8):5043-8. doi: 10.1167/iovs.11-7503.
Clinical trial NCT01596842: Effect of Omega-3 Fatty Acid on Vitamin D Activation
Official title: Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis Patients
Vitamin D Insufficiency
Vitamin D Deficiency
Keywords: Omega-3 fatty acid
vitamin D
ergocalciferol
hemodialysis
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.


Eligibility criteria: Inclusion Criteria:

* Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D \< 30 ng/mL

Exclusion Criteria:

* Patients with a history of active infection within 3 months,
* Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
* Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
* Patients with a history of hospital admission within 3 months,
* Patients with a history of bleeding within 3 months,
* Patients with thrombocytopenia,
* Patients with current use of warfarin,
* Patients with an albumin level \< 3.0 g/dL,
* Patients with malignancy and/or liver cirrhosis

Primary outcomes:
measure: 25-hydroxyvitamin D Levels at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemoglobin Levels at 12 Weeks
timeFrame: 12 weeks
measure: Changes of Calcium Levels
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Change of Intact Parathyroid Hormone
timeFrame: 12 weeks
measure: Change of Fetuin-A Levels
timeFrame: 12 weeks
measure: Change of FGF-23 Levels
timeFrame: 12 weeks
measure: Changes of Phosphorous Levels
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Changes of Erythropoietin Doses
timeFrame: 4 weeks, 8 weeks and 12 weeks
measure: Changes of Phosphate Binder Doses
timeFrame: 4 weeks, 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Won Suk An
Study officials:
References:
citation: Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.