louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04533191: Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
Official title: Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Pseudophakia
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.

Brief summary: The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.


Eligibility criteria: Inclusion Criteria:

1. Patients able to sign informed consent
2. Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.

Exclusion Criteria:

* Inability to sign informed consent
* Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
* Unable to return for light treatments

Primary outcomes:
measure: Binocular uncorrected distance, intermediate, and near visual acuity
timeFrame: Through Month one post-op
measure: Binocular uncorrected depth of focus
timeFrame: Through Month one post-op
Secondary outcomes:
measure: Manifest refraction
timeFrame: Through Month one post-op
measure: Monocular uncorrected distance visual acuity
timeFrame: Through Month one post-op
measure: Monocular best corrected distance visual acuity
timeFrame: Through Month one post-op
measure: Visual Satisfaction
timeFrame: Through Month one post-op
measure: 4th order total eye spherical aberration (Z12)
timeFrame: Through Month one post-op
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
References:
Clinical trial NCT05532891: Bariatric Surgery and COVID-19
Official title: Bariatric Surgery Provision in Response to the COVID-19 Pandemic: Retrospective Cohort Study of a National Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Bariatric Surgery Candidate
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: The Royal College of Surgeons of England
First posted: 2022-09-08
Enrollment: 11545
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018)

Brief summary: The National Bariatric Surgical Registry (NBSR) is a prospectively collected database for all patients undergoing elective bariatric surgery in the UK. It was used to identify patients that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020). Characteristics of this group were compared with a pre-pandemic cohort (one year from 1st September 2018).


Eligibility criteria: Inclusion Criteria:

All patients listed on National Bariatric Surgical Registry (NBSR) that underwent elective bariatric surgery during the pandemic (one year from 1st April 2020) or prior to the pandemic (one year from 1st September 2018) -

Exclusion Criteria:

- Where a variable was 'not recorded' this point was excluded from analysis. For age, gender, procedure type and provider the records were 100% complete, for BMI at time of surgery there was 5% missing data and for other variables the missing value rate was 2% or lower.

Primary outcomes:
measure: Revisions
timeFrame: 1 year
measure: Private
timeFrame: 1 year
Secondary outcomes:
measure: Completed Laparoscopically
timeFrame: 1 year
measure: Length of Stay
timeFrame: 1 year
measure: Surgical Complications
timeFrame: 1 year
measure: Presence of Second Consultant
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Surgery and Cancer, Imperial College London
Study officials:
References:
Clinical trial NCT00131391: A Study of MK0364 in Obese Patients (0364-014)
Official title: A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-18
Enrollment: 2400
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: A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 30-43 kg/m2

Exclusion Criteria:

* History of major psychiatric disorder
* History of seizures or at high risk of developing seizures
* Blood pressure greater than 160/100
* Fasting blood glucose greater than 126 mg/dL
* Triglycerides greater than 600 mg/dL

Primary outcomes:
measure: Decreases body weight; prevention of weight regain; safety and tolerability
timeFrame: 2 Years
Secondary outcomes:
measure: Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity
timeFrame: 2 Years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05171491: LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Official title: Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Solitary Pulmonary Nodule
Multiple Pulmonary Nodules
Keywords: Lung Cancer
Circulating Genetically Abnormal Cells (CGAC)
4-color FISH
Increased/Decreased Risk
Early Lung Cancer Detection
Indeterminate Nodule
Lead sponsor: LungLife AI
Sponsor class: INDUSTRY
First posted: 2021-12-29
Enrollment: 425
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with suspicious indeterminate pulmonary nodules identified incidentally or through a lung cancer screening program. up to 15 institutions geographically distributed across the US.

Brief summary: Correlate performance of LungLB Test with outcome of a scheduled biopsy.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent.
2. Planned biopsy nodule of interest:

   1. is solid ≤3 cm; or
   2. is nonsolid, ground glass opacity, of any size; or
   3. is part solid, where the solid component is no larger than 3cm (maximum diameter).

Exclusion Criteria:

1. Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years.
2. Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.

Primary outcomes:
measure: Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy.
timeFrame: up to 60 days
Secondary outcomes:
measure: Evaluate Clinical Variables With and Without LungLB Test Results
timeFrame: up to 60 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Site 04
state: California
city: Bay Pines
country: United States
facility: Clinical Site 05
state: Florida
city: Miami
country: United States
facility: Clinical Site 03
state: Florida
city: Hines
country: United States
facility: Clinical Site 07
state: Illinois
city: Kansas City
country: United States
facility: Clinical Site 27
state: Kansas
city: Wichita
country: United States
facility: Clinical Site 12
state: Kansas
city: Kansas City
country: United States
facility: Clinical Site 08
state: Missouri
city: Reno
country: United States
facility: Clinical Site 18
state: Nevada
city: New York
country: United States
facility: Clinical Site 01
state: New York
city: Columbia
country: United States
facility: Clinical Site 25
state: South Carolina
city: Houston
country: United States
facility: Clinical Site 02
state: Texas
city: Milwaukee
country: United States
facility: Clinical Site 32
state: Wisconsin
Study officials:
affiliation: LungLife AI
name: Michael Donovan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05794594: 3D Printed Personalized Extendable Prosthesis
Official title: 3D Printed Personalized Extendable Prosthesis Replacement for Limb Preservation in Children With Osteosarcoma: a Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteosarcoma in Children
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with osteosarcoma undergoing prosthesis replacement or limb amputation were admitted to our hospital

Brief summary: The goal of this type of observational study is to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma. The main question it aims to answer is:

Is 3D printed personalized extendable prosthesis replacement has a good outcome in limb salvage pediatric osteosarcoma？

Detailed description: Osteosarcoma is one of the most common primary malignant bone tumors in children and adolescents. In this study, the investigators try to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma.

Eligibility criteria: Inclusion Criteria:

* tumors of the extremities, with moderate soft-tissue invasion
* the neurovascular bundle is not invaded, and the tumor can be excised totally
* no metastatic lesions or metastases can be cured

Exclusion Criteria:

* recurrent tumors
* poorly differentiated tumors
* poor soft-tissue conditions
* neurovascular invasion around tumors
* ineffective chemotherapy with metastasis

Primary outcomes:
measure: Recurrence
timeFrame: 7years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Yuxi Su
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06302894: The Effect of the Nursing Intervention Program on Adolescent Problematic Internet Users
Official title: The Effect of Nursing Intervention Program for Problematic Internet User Adolescents on Appropriate Internet Use, Loneliness and Family Cohesion
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Internet Addiction Disorder
Keywords: Family Cohesion Scale
Internet Addiction Scale
Loneliness Scale for Children
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined.

Detailed description: In this study; The effect of the nursing intervention program (education enriched with web 2.0 tools based on the Health Belief Model) on problematic internet use, loneliness and family harmony in adolescents who use the internet with problems will be determined. This research is a cross-sectional randomized controlled experimental study with a cross-sectional type in the first stage and a pretest-posttest in the second stage.

Eligibility criteria: Inclusion Criteria:

1. Being a secondary school student,
2. Agreeing to participate in the research,
3. Being open to communication and cooperation,
4. Can use web 2.0 tools via smartphone or computer

Exclusion Criteria:

- Having a score of less than 50 points and above 79 points on the Internet addiction scale.

Primary outcomes:
measure: Internet Addiction Scale
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University Faculty of Health Sciences
Study officials:
affiliation: Bolu Abant İzzet Baysal University Faculty of Health Sciences
name: Eda Ceker, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04144894: The Biosonographic Index
Official title: The Biosonographic Index - A Novel Index for the Early Detection of Acute Kidney Injury After Vascular Surgery - an Exploratory Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this exploratory study we explore the use of Shear Wave Elastography to differentiate between Acute Kidney Injury after vascular surgery and among the healthy population.


Eligibility criteria: Inclusion Criteria:

* No history of diabetes or hypertension
* Estimated Glomerular Filtration Rate \> 60 ml/min/m\^2
* Structurally normal kidney on renal ultrasound
* BMI \< 27 kg/m\^2

Exclusion Criteria:

* Prisoners directly admitted from a correctional facility
* Children \< 19 years or under 50 kg body weight if age is unknown
* Patients with end stage renal disease or preexisting glomerular filtration rate less than or equal to 30 mL/min/1.73 m\^2 or need for dialysis
* Patients with end stage heart disease on the cardiac transplant list
* Patients undergoing procedures without vascular surgery
* All transplant patients
* Patients on ventricular assist devices
* Patients undergoing emergency procedures
* Patients with body mass index \> 27kg/m\^2
* Any condition that would impede visualization of the kidneys by ultrasound

Primary outcomes:
measure: Diagnostic factor of Shear Wave Elastography
timeFrame: From the time of Informed Consent being given to 96 hours after consent being given
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ahmed Zaky, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaky A, Beck AW, Bae S, Sturdivant A, Liwo A, Zdenek N, McAnally N, Ahmad S, Meers B, Robbin M, Pittet JF, Tolwani A, Berkowitz D. The bio-sonographic index. A novel modality for early detection of acute kidney injury after complex vascular surgery. A protocol for an exploratory prospective study. PLoS One. 2020 Nov 17;15(11):e0241782. doi: 10.1371/journal.pone.0241782. eCollection 2020.
Clinical trial NCT04299594: Prevalence of Osteoporosis in Sickle Cell Disease
Official title: Prevalence of Osteoporosis in Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: sickle cell disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sickle cell adult patients hospitalized (conventional or day hospitalization) or followed in consultation in internal medicine within the framework of their sickle cell disease at Edouard Herriot Hospital, Lyon, France

Brief summary: Sickle cell disease is the most common single-gene disease in the world. Its prevalence is increasing in France, with patients' life expectancy increasing into developed countries. It mainly affects populations originating from sub-Saharan Africa. Among the chronic bone complications associated with sickle cell disease, osteoporosis has previously been highlighted but remains a poorly known complication in this very particular context. A dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease patients living in France may enable better bone management of these patients in the future, as this problem, specific to their disease, is likely to become more frequent as their life expectancy increases.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteoporosis in black patients with sickle cell disease in France


Eligibility criteria: Inclusion Criteria:

* Black-skinned men and women
* Aged 20 to 40 years old
* Sickle cell patients
* Non-opposition to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* Hemoglobinopathy other than sickle cell disease
* Severe or End Stage Renal Failure
* Long-term corticosteroid therapy (\>3 months)
* History of solid cancer or malignant haemopathy
* History of organ transplantation
* Pregnant or breastfeeding woman
* Psychiatric pathology seriously impeding understanding
* Difficulty understanding oral French

Primary outcomes:
measure: Bone mineral density
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT01057394: Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
Official title: Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types.

1. visually guided ablation (VGA) using the EAS-AC and
2. radiofrequency ablation

Detailed description: The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.

Eligibility criteria: * Symptomatic, Paroxysmal Atrial Fibrillation (AF)
* 18 to 75 Years of age
* Generally good overall health as determined by multiple criteria
* Willing to participate in a study
* Others

Primary outcomes:
measure: Rate of Permanent Pulmonary Vein Isolation of EAS-AC Compared to EAM Guided Radiofrequency Ablation
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
affiliation: The Mount Sinai Hospital, New York City
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03016494: Safety and Pharmacokinetics Study of Fixed Dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects
Official title: A Randomized, Open-label, Oral Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of Fixed-dose Combination of DWJ1386 Compared With Co-administration of DWC20155 and DWC20156 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the safety and pharmacokinetics between co-administration and fixed dose combination of DWC20155 and DWC20156 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* BMI≥18.5 and ≤27.0 kg/m2
* No clinically significant findings
* Age 19-55 years at screening

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 0-24 hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
state: Busanjin-gu
Study officials:
References: