louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05113212: Damages From Macular Grasping During Vitrectomy Comparing Traditional and 3D Microscope
Official title: Randomized, Prospective, Descriptive and Comparative Clinical Study of Macular Grasping Damage in Patients Undergoing Pars Plana Vitrectomy and Peeling of the Internal Limiting Membrane, Operated by Traditional Microscope or NGENUITY® 3D Visualization System With Heads-up Display System. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparison of 3D Visualization and Microscope for VR Surgery
Keywords: Ngenuity
VR Surgery
Pucker
Macular Hole
Lead sponsor: Santa Maria della Misericordia Rovigo Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2021-11-09
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dual-arm, pilot, randomized, prospective, descriptive and comparative clinical study
Primary purpose: TREATMENT

Brief summary: Randomized, prospective, descriptive and comparative clinical study. The comparison is between a group of patients affected by macular pucker or macular hole, whose macular peeling is performed using a traditional optical microscope (Leica F40) - control arm, and a group of patients affected by macular pucker or macular hole whose macular peeling is performed by 3D heads-up microscopy system (NGenuity 3D, Alcon) - experimental arm.

It is a blind study for both the operator that collects data and for the statistician.


Eligibility criteria: Inclusion Criteria:

* Patients affected by macular pucker or macular hole, whose internal limiting membrane peeling need to be performed
* Willing and able to understand and sign an informed consent
* Willing and able to undergo postoperative examinations of the protocol program:
* ≥ 21 years of age, of both sexes and any race

Exclusion Criteria:

* History of ocular trauma or amblyopia.
* Other ocular pathologies (glaucoma, uveitis, diabetic retinopathy, diabetic macular edema, macular degeneration, Irvine Gass Syndrome, degenerative myopia, malformation of the optic disc, i.e.: tilted disc, optic disc pit, posterior staphyloma)
* Multiple procedures programmed during the surgery
* Pregnancy, lactation or programmed pregnancy during the course of the study.

Primary outcomes:
measure: SANFL detection
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Intraoperative time
timeFrame: during surgery
measure: ILM staining
timeFrame: during surgery
measure: ILM grasping
timeFrame: during surgery
measure: Light
timeFrame: during surgery
measure: Surgeon ergonomics
timeFrame: during surgery
measure: BCVA
timeFrame: baseline, 1 month and 3 months after surgery
Other outcomes:
Locations:
city: Rovigo
country: Italy
facility: Santa Maria della Misericordia Hospital
Study officials:
References:
Clinical trial NCT05036512: A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose (SAD/MAD) Study to Evaluate the Safety, Tolerability, PK, and Food Effect of GBT021601, a Hemoglobin S Polymerization Inhibitor, in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sickle Cell Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy participants.

Detailed description: This is a randomized, double-blind, placebo controlled, single and multiple ascending dose study in healthy participants.

Eligibility criteria: Inclusion Criteria:

* Healthy males and females ≥ 18 to ≤ 55 years of age
* Body mass index ≥ 18.0 to ≤ 30.0 kg/m2
* Body weight ≥ 50 kg at screening and Day -1

Exclusion Criteria:

- Positive pregnancy test or currently breastfeeding.

Primary outcomes:
measure: Safety, as assessed by frequency and severity of adverse events (AEs)
timeFrame: 119 days from screening Part A, 134 days from screening Part B
measure: Safety, as assessed by changes in Heart Rate.
timeFrame: 119 days from screening Part A, 134 days from screening Part B
measure: Safety, as assessed by changes in eGFR
timeFrame: 119 days from screening Part A, 134 days from screening Part B
measure: Safety, as assessed by changes in alanine aminotransferase (ALT)
timeFrame: 119 days from screening Part A, 134 days from screening Part B
measure: Safety, as assessed by changes in Blood pressure
timeFrame: 119 days from screening Part A, 134 days from screening Part B
measure: Plasma concentration
timeFrame: 119 days from screening Part A
measure: Plasma concentration
timeFrame: 134 days from screening Part B
Secondary outcomes:
measure: Determine whole blood concentration of GBT021601
timeFrame: 119 days from screening Part A
measure: Determine plasma concentration of GBT021601.
timeFrame: 134 days from screening Part B
measure: Safety, as assessed by changes in QTcF
timeFrame: 119 days from screening Part A, 134 days from screening Part B
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Early Phase Services, LLC
state: Texas
city: Nedlands
country: Australia
facility: Harry Perkins Institute of Medical Research
state: Western Australia
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
city: North Perth
country: Australia
facility: Oxford Compounding
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00660712: Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey
Official title: Evaluation of Patient Characteristics and Treatment Approaches to Patients With Bipolar Disorder in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
patient characteristics
treatment characteristics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 1018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Speciality care outpatient clinic (Psychiatry outpatient clinic)

Brief summary: A registry study to identify the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.


Eligibility criteria: Inclusion Criteria:

* Patients previously or currently diagnosed with bipolar disorder
* Patients (or any of their relatives) who give a written informed consent.

Exclusion Criteria:

* Patients who were previously included in this study.

Primary outcomes:
measure: Identification of the patient-diagnosis-treatment characteristic profile of patients with bipolar disorder in Turkey.
Secondary outcomes:
measure: Evaluation of the time period that elapsed since the diagnosis of bipolar disorder
measure: Evaluation of co-morbid psychiatric diseases
measure: Identification of treatment modalities selected according to the disease phase
measure: Identification of the number of first degree relatives diagnosed with bipolar disorder
measure: Evaluation of the relationship between patient and disease characteristics
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Research Site
city: Afyon
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Aydin
country: Turkey
facility: Research Site
city: Batman
country: Turkey
facility: Research Site
city: Denizli
country: Turkey
facility: Research Site
city: Erzincan
country: Turkey
facility: Research Site
city: Eskisehir
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Malatya
country: Turkey
facility: Research Site
city: Mardin
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Rize
country: Turkey
facility: Research Site
city: Samsun
country: Turkey
facility: Research Site
city: Sivas
country: Turkey
facility: Research Site
city: Trabzon
country: Turkey
facility: Research Site
Study officials:
affiliation: Erenkoy State Hospital for Psychiatric Diseases, Istanbul, Turkey
name: Mustafa Bilici, MD, Assoc. Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03685981: Methods to Improve Preventative Care Uptake
Official title: Methods to Improve Preventative Care Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 3145
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study examines whether providing patients with information on the incentives for following the preventative care guidelines available through their insurance has an impact on the update of these preventative services.


Eligibility criteria: Inclusion Criteria:

* Patients attributed to the New York University Langone Health Clinically Integrated Network and have Medicare or Medicaid coverage (via Healthfirst) who are due for gaps in care

Exclusion Criteria:

* Any patients who do not meet the inclusion criteria

Primary outcomes:
measure: % of care gaps closed
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
References:
Clinical trial NCT05975281: Neuropathic Pain Symptoms in Arthritis
Official title: Comparison of Neuropathic Pain Symptoms in Hand Osteoarthritis and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuropathic Pain
Keywords: hand osteoarthritis
neuropathic pain
neuropathic symptom
rheumatoid arthritis
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid arthritis who applied to the Physical Medicine and Rehabilitation Clinic of Şişli Hamidiye Etfal Training and Research Hospital.

Brief summary: It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid arthritis.

Detailed description: The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid arthritis who applied to the Physical Medicine and Rehabilitation Clinic of our hospital will be included. In both patient groups, the duration, character and treatments of their complaints will be compared. Neuropathic pain will be evaluated with the Visual Analog Score (VAS), Dolor Neuropathic 4 Questions (DN-4) and Pain Detect pain questionnaire.

Eligibility criteria: Inclusion Criteria:

* Presence of Hand Osteoarthritis and Rheumatoid Arthritis
* Presence of neuropathic complaints

Exclusion Criteria:

* History of hand injury, peripheral nerve injury, fracture, and hand operation in the last 3 months
* Do not want to participate in the study

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Day 1
measure: DN-4
timeFrame: Day 1
measure: Pain detect pain questionnaire
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
References:
Clinical trial NCT02193581: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
Official title: Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging: the MDS (Melanoma Detecting System)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Lesion
Lead sponsor: Orlucent, Inc
Sponsor class: INDUSTRY
Collaborators: name: Hadassah Medical Organization
First posted: 2014-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individual referred by a dermatologist or plastic surgeon for a skin biopsy or lesion excision.

Brief summary: The use of MDS to access the presence of melanoma in the skin.

Detailed description: A topical agent is applied to suspicious skin lesions and imaged. The images are analyzed to provide a score that correlates with the probability for the presence of melanoma in the lesion.

Eligibility criteria: Inclusion Criteria:

* Individuals with skin lesion with one or more of the ABCDE features and recommended for a skin biopsy.
* The lesion is accessible to the imaging device, with at least 1 cm of skin around the lesion that is accessible to the MDS.
* Male and female ≥ 21 years old.
* Subject is capable of giving written informed consent.
* Primary excision.

Exclusion Criteria:

* The lesion is less than 1 cm from the eyes.
* The lesion is on the palms of hands or soles of the feet.
* Mucosal lesion.
* Pregnant females.
* Low study procedure compliance.
* Patients who are mentally or physically unable to comply with all aspects of the study.
* Undergoing chemotherapy.
* Minor or legally incompetent and not able to sign the consent form.
* Patient previously tested by MDS and was diagnosed with melanoma during the study.
* Sensitivity to fluorescein

Primary outcomes:
measure: The MDS produces a score between 1 to 10.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Sharon Merims, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174081: ARDS Prediction Score in Critically Ill Patients in China
Official title: ARDS Prediction Score in Critically Ill Patients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Septic Shock
Keywords: mechanical ventilation, ARDS, Ventilator strategy, outcome
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 698
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: patients have the risk of ARDS

Brief summary: ARDS is a severe disease, it's important to predict the incidence of ARDS.

Detailed description: From January 1 to January 31, 2012 and from January 1 to January 10, 2013 , all patients admit to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Eligibility criteria: Inclusion Criteria:

Critically ill patients who admitted into participating ICU

Exclusion Criteria:

Patients with chronic pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, lung cancer, pulmonary fibrosis and tuberculosis Age less than 18 years old Pregnancy Died within 24 hours from ICU admission ARDS patients who diagnosed 24hours before ICU admission Referral from other hospital to participating ICU Lack of data of ARDS risk factors

Primary outcomes:
measure: incidence of ARDS
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jianfeng Xie, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881881: Study Evaluating the Clinical and Therapeutic Management of Rheumatoid Arthritis in Spain
Official title: Clinical and Therapeutic Management of the Rheumatoid Arthritis in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with early RA and established RA treated in Rheumatology units in a real-world setting

Brief summary: This is an epidemiological, multicenter, retrospective study to analyze the management of rheumatoid arthritis (RA) in usual clinical practice in Spain. Two groups of patients will be analyzed: individuals who have had RA for two years or less (the "early RA" group) and individuals who have had RA for more than 2 years and who currently meet the ACR criteria for RA (the "established RA" group).


Eligibility criteria: Inclusion criteria:

* Group 1: early RA : patients with disease lasting 2 years or less, considered by the investigator as an early RA
* Group 2: established RA: patients with disease lasting more than 2 years who meet the ACR criteria for RA

Exclusion criteria:

* Patients with any rheumatic disease different from RA
* Participation in any clinical trial or study in the last 12 months

Primary outcomes:
measure: Therapeutic management of the RA (actual and 12 month follow-up) in a real-world setting. Descriptive analysis of sociodemographics and clinical variables for patients and sorted by group (early and established RA) for the last 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Measurements of diagnostic and outcomes used in the common clinical practice. Degree of follow-up of the actual Spanish consensus on clinical and therapeutic management of patients with RA
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01404481: Clean Intermittant Self Catheterisation: A Trial Comparing Single Use vs Reuse of Nelaton Catheters
Official title: Clean Intermittant Self Catheterisation: A Randomised Control Trial Comparing Single Use vs Reuse of Nelaton Catheters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Retention
Keywords: Urinary retention
CISC
Single use
Re use
Lead sponsor: St George Hospital, Australia
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Continence clinic, community patients, hospital patients

Brief summary: The purpose of the study is to compare single use of catheters with reuse of catheters for intermittant self catheterisation.

Detailed description: Patients with voiding dysfunction and chronic urinary retention are taught the technique Clean Intermittent Self Catheterisation (CISC) by specialist Nurse Continence Advisors.

For several decades, patients have been taught to catheterise using a "clean" technique where they rinse their catheter under tap water and store the catheter in a sterile solution (e.g. Milton). The catheter is re-used for up to one week. The risk of urinary tract infection (UTI) was known to be minimal (and certainly much less than having a permanent indwelling catheter).

Recently, the Therapeutics Goods Administration has issued a guideline that CISC catheters should be "single-use items" but no data to support this guideline appears to have been collected.

The aim of this project is to assess the incidence of urinary tract infection (UTI) when comparing single-use catheters with re-use of catheters for CISC, and to determine the cost differences between the two methods.

Eligibility criteria: Inclusion Criteria:

* over 18 years old
* CISC \> 2/day
* No current symptomatic UTI
* Willing to change catheter use method

Exclusion Criteria:

* Symptomatic Urinary Tract infection despite treatment
* \<18 years old

Primary outcomes:
measure: Rate of Urinary Tract Infection
timeFrame: 16 weeks
Secondary outcomes:
measure: Economic Cost
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Pelvic Floor Bladder Unit St George Hospital
state: New South Wales
Study officials:
affiliation: St George Hospital
name: Kate Moore, A/Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: St George Hospital
name: Dr Emmanuel Karantanis, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.