louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03197896: Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods
Official title: A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-06-23
Enrollment: 296
Sex: MALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial studies how well an educational intervention works in increasing knowledge about prostate cancer in high-risk neighborhoods. Learning about prostate cancer and the pros and cons of screening for prostate cancer may increase knowledge about prostate cancer while decreasing anxiety and concerns about prostate cancer screening.

Detailed description: PRIMARY OBJECTIVES:

I. To identify neighborhoods with disproportionately high rates of advanced prostate cancer and describe patient- and neighborhood-level risk factors associated with the high-risk neighborhoods.

II. To develop, using a mixed methods approach, a targeted educational intervention about prostate cancer for men who live in high risk neighborhoods.

III. To test the impact of the targeted intervention on levels of knowledge, anxiety, and informed decision making about prostate cancer (PCa) screening.

IV. To observe the rates of PCa screening in the intervention and control groups.

Eligibility criteria: Inclusion Criteria:

* Focus groups consisting of men who live, work, or worship in the 4 predetermined neighborhoods
* Currently reside in one of the four selected high risk neighborhoods

Exclusion Criteria:

• Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen \[PSA\] or digital rectal examination \[DRE\]) within the past 12 months

Primary outcomes:
measure: Themes identified by focus group transcripts
timeFrame: Up to 4 years
measure: Change in prostate cancer knowledge as measured by a 17-item scale
timeFrame: Baseline to up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Charnita Zeigler-Johnson, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00759096: Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Official title: Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Keywords: bilateral implantation
ReSTOR Aspheric IOL
uniocular unaided distance
binocular unaided distance
intermediate visual acuity
near visual acuity
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.


Eligibility criteria: Inclusion Criteria:

* ≥21 years of either gender or any race
* Potential post-op VA 20/20
* Pre-op astigmatism ≤ 1.0D
* Able to sign the informed consent
* Able to complete all required postoperative visits
* Planned cataract removal by phaco
* Clear intraocular media other than cataract

Exclusion Criteria:

* Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
* Any corneal pathology and previous corneal refractive surgery
* Patients with unrealistic expectations in anticipated post-op VA
* Happy to wear glasses
* Occupational night driver

Primary outcomes:
measure: Near Uncorrected Visual Acuity(UCVA
timeFrame: 6 months after surgery of 2nd eye
Secondary outcomes:
measure: Contrast Sensitivity
timeFrame: 6 months after sugery of the 2nd eye
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT03580096: Core Stability and Parkinson Disease
Official title: Effects of Core Stability Exercise in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 44
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: Patients with Parkinson's Disease frequently present impaired postural control that leads to loss of stability and increased risk of falls.Core system, includes passive structures of the thoracolumbar spine and pelvis that work as a unit to stabilize the body and spine against forces generated from distal body segments as well as forces generated from expected or unexpected perturbations.The objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.

Detailed description: Core muscle coordination is important because lack of sufficient core muscle coordination can lead to decreased efficiency of postural control and functional activity. Clinical manifestations of patients with Parkinson's Disease include postural instability. Core system could be relevant to be included in an intervention. Thus, the objective of this study was to evaluate the effects of an intervention based on core stability in patients with Parkinson's Disease.

Eligibility criteria: Inclusion Criteria:

* Parkinson's Disease diagnosis.
* Stable medication usage
* Able to maintain standing independent

Exclusion Criteria:

* Cognitive impairment
* Comprehension deficits that prevented them from following verbal commands

Primary outcomes:
measure: Change in dynamic balance
timeFrame: Change from baseline dynamic balance at 8 weeks
Secondary outcomes:
measure: Balance confidence
timeFrame: Baseline, 8 weeks
measure: Static balance
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
References:
Clinical trial NCT04660396: Monitoring Outpatient Blood VolumE in Heart Failure
Official title: Monitoring Outpatient Blood VolumE in Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Plasma Volume
Red Blood Cell Volume
Blood Volume
Diuresis
Lead sponsor: Daxor Corporation
Sponsor class: INDUSTRY
Collaborators: name: Geisinger Clinic
First posted: 2020-12-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted to Geisinger Medical Center with a diagnosis of acute heart failure.

Brief summary: In patients discharged following heart failure treatment, the consistency of blood volume status and components over time is unknown. The primary objective is to describe the rate of change, if any, of the plasma volume and red blood cell volume following hospitalization and discharge of patients with heart failure.

Detailed description: Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases. High 30-day readmission and mortality rates have persisted despite advances in care. Clinical guidelines suggest blood volume assessment and clinical management to euvolemia or normal blood volume, but standard methods of blood volume diagnosis have been shown to be unreliable. FDA-cleared Blood volume analysis (BVA) has been used to quantify otherwise undiagnosed blood volume derangements in heart failure and other indications. Also, care guided by BVA has been demonstrated to improve inpatient heart failure readmission and mortality. A similar analysis has not previously been performed immediately following hospital discharge, though this period is understood to be challenging due to high variability of patient status, physiology, and compliance.

This is a prospective, single-center, observational open-label study. The primary objective is to quantify changes to plasma volume and red blood cell volume over a 12 week period post-discharge.

Eligibility criteria: Inclusion Criteria:

* Hospitalized male and female patients with primary or secondary admission diagnosis of acute heart failure exacerbation
* \> 18 years of age
* Able and willing to provide consent
* Reduced or preserved LVEF

Exclusion Criteria:

* Diagnosed with current acute strokes
* Pregnant women
* Severe hypotension requiring resuscitation, intubation or circulatory support
* Cardiogenic shock
* Patients with known cardiac amyloid and hypotension
* Known allergy to iodine or iodinated albumin

Primary outcomes:
measure: Quantify volume shifts in post discharge heart failure patients
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Brendan Carry
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02286596: Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
Official title: Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Homozygous Familial Hypercholesterolemia
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with homozygous familial hypercholesterolemia already treated with LDL apheresis using both systems being compared (HELP vs Dextran)

Brief summary: Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved to be a reliable method to decrease LDL-C concentrations and therefore decrease cardiovascular disease risk in HoFH. The objective of this crossover study was to compare efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and LDL particles size in a cohort of HoFH subjects.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-65 years
* Subjects with homozygous familial hypercholesterolemia:
* Carrier of a mutation in the LDL receptor gene

Exclusion Criteria:

* Subjects with a previous history of cardiovascular disease
* Subjects with Type 2 diabetes
* Were pregnant or nursing;
* Subjects with a history of cancer
* Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases
* Subjects with a secondary hyperlipidemia due to any cause
* History of alcohol or drug abuse within the past 2 years
* hormonal treatment
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

Primary outcomes:
measure: Change in plasma lipid levels between the two lipid apheresis treatment
timeFrame: At the end of the two lipid apheresis (Week 0 and 2)
Secondary outcomes:
measure: Change in plasma adhesion molecule levels between the two lipid apheresis treatment
timeFrame: At the end of the two lipid apheresis (Week 0 and 2)
measure: Change in plasma inflammatory marker levels between the two lipid apheresis treatment
timeFrame: At the end of the two lipid apheresis (Week 0 and 2)
measure: Change in LDL particle size between the two lipid apheresis treatment
timeFrame: At the end of the two lipid apheresis (Week 0 and 2)
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institute of Nutrition and Functional Foods (INAF)
Study officials:
affiliation: Laval University
name: Patrick Couture, MD, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01342016: A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
Official title: A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lupus Nephritis
Keywords: prograf
nephritis
leflunomide
immunosuppressant
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma China, Inc.
First posted: 2011-04-26
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.


Eligibility criteria: Inclusion Criteria:

* body weight 40-100kg
* diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997)
* diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
* 24hr proteinuria ≥2g and/or active urinary sediments

Exclusion Criteria:

* receiving immunosuppressant
* receiving routine treatment of tacrolimus and leflunomide within 1 month
* receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study
* history of allergy to tacrolimus and leflunomide
* anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment
* planning to receive kidney transplantation or in the near future or having a history of undergoing kidney transplantation
* serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) \< 30ml/min
* diabetes mellitus patients

Primary outcomes:
measure: remission rate (partial remission + complete remission)
timeFrame: at 6 months after treatment
Secondary outcomes:
measure: urinary protein excretion for 24 hrs (24hr proteinuria)
timeFrame: at 12 weeks and 24 weeks
measure: serum albumin level
timeFrame: at 12 weeks and 24 weeks
measure: serum creatinine level
timeFrame: at 12 weeks and 24 weeks
measure: estimated glomerular filtration rate (eGFR)
timeFrame: at 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Fujian
country: China
city: Hubei
country: China
city: Hunan
country: China
city: Jiangsu
country: China
city: Jilin
country: China
city: Liaoning
country: China
city: Shandong
country: China
city: Shanghai
country: China
city: Shanxi
country: China
city: Sichuan
country: China
city: Zhejiang
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT01717716: Sugars-containing Beverage and Food Intake in Children
Official title: Role of Sugars in Solution on Subjective Appetite and Short-term Food Intake in Normal Weight 9-14 Year Old Boys
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: boys
obesity
glucose
sucrose
high-fructose corn syrup-55
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Mount Saint Vincent University
First posted: 2012-10-30
Enrollment: 15
Sex: MALE
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose is to determine the effect of sugars in solution on food intake and subjective appetite in 9- to 14-year-old normal weight boys. The investigators hypothesize that food intake after all sugars-containing solutions will be decreased in comparison to the control solution, with similar reductions in FI between high-fructose corn syrup -55 (HFCS-55) and sucrose. Food intake will be measured 60 minutes after consumption of 50g of HFCS-55, sucrose or glucose, or a control treatment. Subjective appetite will be measured at 15, 30, 45, 60 and 90 minutes.


Eligibility criteria: Inclusion Criteria:

* Healthy, boy, born at full term and normal birth weight

Exclusion Criteria:

* Girl, on restricted diet, taking medication that affect appetite or food intake, have significant learning, behavioral, or emotional difficulties

Primary outcomes:
measure: Food intake (kcal)
timeFrame: measured at 60 minutes after the treatment
Secondary outcomes:
measure: Subjective appetite (mm)
timeFrame: 0-90 minutes
Other outcomes:
Locations:
city: Bedford
country: Canada
facility: Department of Applied Human Nutrition
state: Nova Scotia
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02930616: A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastric Intestinal Metaplasia
Confocal Laser Endomicroscopy
Operative Link on Gastric Intestinal Metaplasia
Biopsy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40 years or older with Helicobacter pylori infection;
* Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
* Pregnancy or breastfeeding;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by pCLE.
timeFrame: 9 months
measure: the detection rate of each OLGIM (the Operative Link on Gastric Intestinal Metaplasia) stage by WLE.
timeFrame: 9 months
Secondary outcomes:
measure: the overall detection rate of GIM by pCLE.
timeFrame: 9 months
measure: the overall detection rate of GIM by WLE.
timeFrame: 9 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Li Yanqing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05073016: The Effect of Intermittent Theta Burst Stimulation on Motor Learning in Healthy Adults
Official title: The Effect of Intermittent Theta Burst Stimulation on Motor Learning in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2021-10-11
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study investigates the effect of different application frequencies of intermittent theta burst stimulation on motor learning in healthy adults.


Eligibility criteria: Inclusion Criteria:

* being at the age of 40-75 years

Exclusion Criteria:

* visual disability
* cognitive or psychiatric problems such as dementia, depression, etc.

Primary outcomes:
measure: Finger Taping Task
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Bakırköy Ruh ve Sinir Hastalıkları Hastanesi
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Burcu Ersöz Hüseyinsinoğlu, PhD
role: STUDY_DIRECTOR
References: