louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04216108: Comparative Study 23G Versus 27G Vitrectomy
Official title: Comparative Study 23G Versus 27G Vitrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreoretinal Surgery
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 80
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: Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18
* No prior vitrectomy surgery in the study eye
* No prior inclusion in this trial
* Scheduled for vitrectomy for floater removal or macular surgery

Exclusion Criteria:

* Patients with serious heart, lung, liver, or kidney dysfunction
* Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
* Patients with history of drug abuse or alcoholism
* Patients participating in other drug or medical device clinical trials before screening for this trial
* Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
* Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

Primary outcomes:
measure: Changes in post-operative outcome of pain
timeFrame: 1 week
measure: Changes in post-operative outcome of redness
timeFrame: 1 week
measure: Changes in post-operative outcome of measured inflammation
timeFrame: 1 week
measure: Changes in post-operative outcome in grading of anterior chamber cells
timeFrame: 1 week
Secondary outcomes:
measure: Post-operative parameter: Visual acuity
timeFrame: 1 week
measure: Post-operative parameter: Intraocular pressure
timeFrame: 1 week
measure: Post-operative parameter: Pain assessment
timeFrame: 1 week
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven (UZ Leuven)
state: Vl-Brabant
Study officials:
affiliation: UZ Leuven
name: Peter Stalmans, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00470808: The Effect of a Natural Polyphenolic Extract From Pomegrnate (POMX) on the Development of Atherosclerosis in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Keywords: Minors
Enrollment in another study
Males
HBA1C greater than 7
Drug therapy for DM
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-05-08
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diabetes is a highly atherogenic disease. Pomegranate juice has impressive antioxidant properties. It has been proven to decrease oxidant stress and to cause the regression of atherosclerotic plaques in hypercholestrolemic and diabetic patients.Furthermore it has been proven to potentiate the biologic activity of the enzyme paraoxonase 1 which is very important in preventing atherosclerosis. The study will try to prove that a polyphenolic extract from pomegranate (POMx) has the same desired effects.


Eligibility criteria: Inclusion Criteria:

* Males
* HBA1C\>7%
* Drug therapy given for DM

Exclusion Criteria:

* Age\<18
* Inclusion in another study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ha'Emek Medical Center
Study officials:
affiliation: Ha'Emek Medical Center
name: Wasseem Rock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01139008: Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
Official title: Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Manifestations
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the tolerability of MetroGel® (metronidazole gel) 1% to Finacea® (azelaic acid) Gel 15% in subjects with healthy skin applied according to product labeling for three weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults (ages 18 years or older)
* Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
* Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Primary outcomes:
measure: Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3
timeFrame: baseline to week 3
Secondary outcomes:
measure: Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.
timeFrame: Day 22
measure: 6 Question Subject Preference Survey at Week 3
timeFrame: week 3
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Thomas J. Stephens and Associates, Inc.
state: Texas
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04472208: AMS Evaluation Study
Official title: Evaluation Clinical Study Of The Ambulatory Monitoring Solution (AMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Monitoring
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2020-07-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A study to evaluate the operational and functional features of the Ambulatory Monitor Solution (AMS) as well as the ease of use of the system.

Detailed description: The study is going to be conducted to collect feedback from the users about operation of AMS collect parameter raw data from patients in hospital ward setting using the investigational system for use in current and future AMS engineering and regulatory purposes as deemed appropriate by the Sponsor.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or older (≥18 years);
2. Able and willing to provide written informed consent independently.

Exclusion Criteria:

1. Have previously participated in this study (no subject may participate more than once);
2. Have an implantable pacemaker;
3. Diagnosed with infection requiring isolation; OR
4. Known to be pregnant and/or breast feeding;

Primary outcomes:
measure: User feedback survey about the use of the Ambulatory Monitoring Solution
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
measure: Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues
timeFrame: 1 year
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: St. Marys Hospital, London
name: Meera Joshi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01467908: Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
Official title: Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vegetative State
Stroke
Brain Injury
Keywords: Diagnosed vegetative state after stroke or traumatic brain injury
Lead sponsor: Clinical Institute of the Brain, Russia
Sponsor class: OTHER
Collaborators: name: City Hospital No 41, Ekaterinburg, Russia
First posted: 2011-11-09
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It has already been demonstrated that mental imagining of the complex motor act, such as limb lifting, can evoke the activation of the involved motor centres even if it doesn't result in movement due to paresis. Aim of the study: using the navigated brain stimulation system create a new diagnostic model for the differential diagnostics between the vegetative state and the minimally conscious state. If the investigators could get from patient the efferent motor response after a verbal command, his level of conscious should not be defined less than the minimally conscious state.


Eligibility criteria: Inclusion Criteria:

* diagnosed vegetative state
* age 20-85

Exclusion Criteria:

* oncological history
* cardiac pacemakers and other metal implants
* Modified Ashford Scale scores 3 and more
* predisposing disease with motor neurologic impairment

Primary outcomes:
measure: MEP(motor evoked potential) parameter: latency
timeFrame: within the first minute after a verbal command
Secondary outcomes:
measure: MEP(motor evoked potential) parameter: amplitude
timeFrame: within the first minute after a verbal command
measure: MEP(motor evoked potential) parameter: motor threshold
timeFrame: within the first minute after a verbal command
measure: conscious state
timeFrame: within the first 6 months after NBS mapping
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Clinical Institute of Brain
state: Sverdlovsk region
Study officials:
affiliation: Clinical Institute of Brain, Ural State Medical Academy
name: Andrey A Belkin, Prof., MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175108: Diet and Activity in Cerebral Palsy
Official title: DIET, ACTIVITY AND MEDICAL CO-MORBIDITIES IN ADOLESCENTS and ADULTS WITH CEREBRAL PALSY: WHAT ARE THE EFFECTS ON THE METABOLIC PROFILE?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
Adolescents
Adults
Diet
Activity
Metabolic Syndrome
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents (16-17) and adults with cerebral palsy

Brief summary: This study aims to fill a gap in the literature, identify relevant clinical measures, and provide insight into the independent modifiable risk factors of obesity in the CP population with the long-term goal of improving screening, management and prevention of obesity in this at-risk and underserved population.


Eligibility criteria: Inclusion Criteria:

* Adolescent and adult subjects 16-89 years with a diagnosis of Cerebral Palsy

Exclusion Criteria:

* Concurrent severe neurologic or other medical diagnosis that is likely to be contributing to the subject's functional impairment, as determined by the study investigators. For example, associated spinal cord injury.
* Subjects with major limb amputations
* Pregnant or lactating females

Primary outcomes:
measure: Calories per day
timeFrame: 24 hour dietary recall
measure: Total saturated fats per day
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References:
Clinical trial NCT05457608: Clinical Evaluation of Two Multifocal Contact Lenses
Official title: Clinical Evaluation of Clariti Monthly Multifocal and Clariti 1 Day Multifocal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 42
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received Lens A and then Lens B in fixed-sequence order.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

Detailed description: This is a single-blind, interventional, prospective, direct refit, bilateral wear study.

Eligibility criteria: Inclusion Criteria:

* Is at least 42 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Habitually wears multifocal soft contact lenses, or sphere lenses for monovision, or sphere lenses for monovision, or sphere lenses for distance vision correction and use spectacles for near vision correction, for the past 3 months minimum.
* Has refractive astigmatism no higher than -0.75DC.
* Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D.
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS).

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.

Primary outcomes:
measure: Subjective Comfort Ratings on Insertion
timeFrame: At insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: School of Optometry Clinic, National Autonomous University (UNAM)
Study officials:
affiliation: School of Optometry, National Autonomous University (UNAM)
name: Rubén V Guerrero, MSc, FIACLE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545608: Safety and Efficacy of Restylane Vital for Skin Rejuvenation of Dorsal Hands
Official title: A Randomised, Multi-centre, Evaluator-blinded, Split-hand, no Treatment-controlled Study to Evaluate the Safety and Efficacy of Restylane Vital for Skin Rejuvenation of the Dorsal Hands in Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dorsal Hands
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 109
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 study is to determine the safety and efficacy of using Restylane Vital for skin rejuvenation of the dorsal hands. Assessment of improvement of skin structure will be done by a blinded evaluator.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Chinese origin
* Subject willing and able to comply with the requirements of the study and agrees to adhere to the visit schedule and to be compliant to the study instructions

Exclusion Criteria:

* Any previous non-permanent implant/filler in the hands
* Any mesotherapy or resurfacing procedure in the hands within 6 months prior to baseline
* Any previous hand surgery
* Any fibrosis or scarring or deformities on the hands
* Advanced photoaged/photodamaged skin

Primary outcomes:
measure: The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
city: Shanghai
country: China
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References:
Clinical trial NCT05339308: Effects of Magnesium Oil Application on the Muscle Contractile Properties
Official title: Effects of Magnesium Oil Application on the Muscle Contractile Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnesium
Skeletal Muscle Contraction Properties
Keywords: Tensiomyography
Skeletal Muscle
Contractile Properties
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2022-04-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: OTHER

Brief summary: This study will aim to investigate the effects of magnesium oil administration on skeletal muscle contractile properties.

Detailed description: Aim: This study will aim to investigate the effects of magnesium oil administration on skeletal muscle contractile properties (SMcp).

Design: Randomized controlled study

Participants: For this purpose, investigators will recruit 40 recreationally active and healthy adults of both sexes (18-35 years of age).

Methods: The experimental leg (EXP) will receive the 10 sprays of magnesium oil (20 mg per spray) that will be topically applied to the skin covering the knee extensor muscles, whereas the control leg (CON) will receive 10 sprays of natural mineral-free oil. The vastus lateralis SMcp will be measured by using a tensiomyography (TMG) device before application (PRE) and after 10 (POST10), 20 (POST20), 30 (POST30), 40 (POST40), and 50 (POST50) minutes of application onset, respectively.

Eligibility criteria: Inclusion Criteria:

* healthy, recreationally active adults, no history of neuromuscular and musculoskeletal diseases

Exclusion Criteria:

* if some of the criteria are not met

Primary outcomes:
measure: Skeletal Muscle Contractile Properties
timeFrame: 75 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Masaryk University
city: Ljubljana
country: Slovenia
facility: Faculty of Sport
Study officials:
affiliation: Faculty of Sport
name: Armin Paravlic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05183308: Combined Drug Therapy in Lateral Fragility Fractures of the Femur
Official title: The Effect of Combined Drug Therapy in Lateral Fragility Fractures of the Femur:a Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Keywords: fragility lateral femoral fractures
bisphosphonates
clodronic acid
bone density
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between May 2019 and March 2020 with lateral fragility fracture were prospectively recruited.

Brief summary: It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients).

One independent observer performed clinical, biochemical and functional evaluations at T0 (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level, serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were administered at each evaluation.


Eligibility criteria: Inclusion Criteria:

* femur fractures type 31-A1, A2, (Muller ME, Nazarian S, Kock P et al.);
* age 60 - 85 years;
* co-operative patients;
* Body Mass Index (BMI) \< 30 Kg/m²;
* patients treated by intramedullary nailing surgery (PFNA Synthes®);
* patients with osteoporosis disease if T-Score\< -2,5;

Exclusion Criteria:

* patients with heart, kidney, neurological diseases;
* patients with metabolic and systemic disease (rheumatoid arthritis, diabetes mellitus);
* previous surgery or severe osteoarthritis of lower limbs;
* specific drugs treatments such as anticoagulants or psychiatric drugs.

Primary outcomes:
measure: Change in Visual Analogic Scale
timeFrame: Day 1; Month 12 (after surgey)
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Study officials:
References: