louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00431899: Effects of Omega 3 in Hemodialysis Patients
Official title: Effets of Fish Oil on Metabolic Fate of an Oral Glucose Load in Patients With End Stage Renal Disease Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
End Stage Renal Disease
Keywords: nutrition
omega 3 fatty acids
insulin resistance
Lead sponsor: Laboratoire Régional de Nutrition Humaine
Sponsor class: OTHER
First posted: 2007-02-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of the study was to determine the effects of a 3-week fish oil oral supplementation on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* hemodialysis at least 6 months duration end stage renal disease

Exclusion Criteria:

* - Age \< 18 y ou \> 75 y
* Hemodialysis \< 6 months
* Diabetes, obesity
* allergy to fish
* Asthma
* glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin
* erythropoïetin \< 3 months
* Cancer
* Hemoglobin \< 11 g/l
* disease \< 1 month
* pregnancy
* respiratory insufficiency
* intensive sport practice
* refusal

Primary outcomes:
measure: plasma glucose utilization
measure: glucose-induced thermogenesis
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Laboratoire Régional de Nutrition Humaine
Study officials:
affiliation: CHU Cavale Blanche F-29200 Brest
name: Jacques Delarue, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312299: Posterior Capsule Opacification Study
Official title: Posterior Capsule Opacification After Implantation of Square Edge PMMA, Round Edge PMMA and Acrysof Intraocular Lenses: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Double-Blind Method
Clinical Trials, Randomized
Lenses, Intraocular
Prospective Studies
PMMA
Visual acuity
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2006-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: First object is to compare square edge PMMA with round edge PMMA IOL where the materials are same. Next objective is to compare square edge PMMA IOL with Acrysof IOL where the materials are different

Detailed description: Cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. Posterior Capsular Opacification (PCO) remains the most frequent long term complication. This is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (IOL)

The combination of IOL material and a sharp edged design is effective in preventing PCO. Aurolab has developed 360 degree square edge IOL with polymethyl methacrylate (PMMA)

100 bilateral senile cataract patients are going to be recruited. First group of 50 patients will receive square edge PMMA in one eye and round edge PMMA in fellow eye. Another group of 50 patients will receive square edge PMMA in one eye and acrysof in fellow eye. PCO will be assessed during each follow up using EPCO software.

Eligibility criteria: Inclusion Criteria:

* Age 40 to 65 years
* Bilateral senile cataract
* Pupil should be at least 7mm dilated
* Nuclear sclerosis grade I, II and III
* Patient willing for second eye surgery within 3 months

Exclusion Criteria:

* Debilitated old patients
* Cardiac and serious illness
* Intraoperative complications including PC rent, Zonular dialysis and Rhexis tear
* Inherent zonular weakness
* Glaucoma patients
* Relative afferent papillary defect (RAPD)
* Shallow anterior chamber
* Pseudoexfoliation
* Traumatic cataract
* Uveitis and complicated cataract
* One eyed patients
* Corneal pathology
* Post segment pathology including diabetic retinopathy
* Dense Posterior subcapsular cataract (PSCC) and Posterior polar cataract (PPC)
* High myopic and hyperopic patient

Primary outcomes:
measure: PCO
timeFrame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Secondary outcomes:
measure: Visual Acuity
timeFrame: 1 Day, 1 Month, 6 Month, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
Study officials:
affiliation: Aravind Eye Hospital, Madurai
name: Haripriya Aravind, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06276699: Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy
Official title: Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: University of Peradeniya
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.


Eligibility criteria: Inclusion Criteria:

* 35-60 years
* Neck pain \> 3 months
* Clinical Prediction Rules - Positive Spurling's test (+) Distraction test (+) Upper limb tension test A (+) Cervical rotation on affected side \< 60

Exclusion Criteria:

Presence of any signs or symptoms of medical red flags

* Less than 3(positive) items for the CPR
* Bilateral arm radiating pain
* Osteoporosis
* Tumor
* Whiplash injury
* Pregnancy woman
* Rheumatoid arthritis
* Post-surgery to cervical/thoracic spine

Primary outcomes:
measure: Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline.
timeFrame: 2 times a week for 6 weeks
Secondary outcomes:
measure: Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline.
timeFrame: 2 times a week for 6 weeks
measure: Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline
timeFrame: 2 times a week for 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01198899: Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
Official title: Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Hypertrophy
Keywords: Fabry-Anderson disease
gen mutation
left ventricular hypertrophy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 540
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: patients with left ventricular hypertrophy

Brief summary: The purpose of this study is to determine the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study is a screening study


Eligibility criteria: Inclusion Criteria:

* All patients over 18 years undergoing a routine echocardiography in the participating hospitals
* Both genders will be considered.
* Patients can be included if on 2D echocardiography the maximal septal wall thickness \> 13 mm and/or the posterior wall thickness \> 13 mm. The limit for inclusion is kept relatively low to detect early forms of Fabry cardiomyopathy.

Primary outcomes:
measure: Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography
timeFrame: At baseline T0
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: AZ Imelda
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Gent
country: Belgium
facility: Maria Middelares
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis
city: Knokke-Heist
country: Belgium
facility: AZ Oostkust
city: Limburg
country: Belgium
facility: ZOL
city: Ronse
country: Belgium
facility: AZ Zusters van Barmhartigheid
Study officials:
affiliation: University Hospital Ghent, Belgium
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terryn W, Deschoenmakere G, De Keyser J, Meersseman W, Van Biesen W, Wuyts B, Hemelsoet D, Pascale H, De Backer J, De Paepe A, Poppe B, Vanholder R. Prevalence of Fabry disease in a predominantly hypertensive population with left ventricular hypertrophy. Int J Cardiol. 2013 Sep 10;167(6):2555-60. doi: 10.1016/j.ijcard.2012.06.069. Epub 2012 Jul 16.
Clinical trial NCT03438799: COMMUNITY STUDY- A Study to Collect Information for the Cordio System
Official title: A Multi-Center Observational Study to Collect Information Related to the Clinical Significance and Performance of the Cordio System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Cordio Medical
Sponsor class: INDUSTRY
First posted: 2018-02-20
Enrollment: 500
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: Patients with NYHA 2-3. All patients must meet eligibility criteria.

Brief summary: This is a multi-center, observational, non-interventional, prospective, Single-arm, open study for database establishment for R\&D purposes. R\&D data will be analyzed retrospectively in order to validate algorithm efficacy.

The study will be conducted in the following settings: outpatinets clinics


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years.
2. Symptomatic Heart Failure Patient.
3. The patient is willing to participate as evidenced by signing the written informed consent.
4. Male or non-pregnant female patient.

Exclusion Criteria:

1. Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
2. Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
3. Patient with severe alcohol or drug use.
4. Psychological instability, inappropriate attitude or motivation.
5. Patient with life threatening debilitating disease other than cardiac.
6. Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Primary outcomes:
measure: R&D Database & Efficiency
timeFrame: 2 years
Secondary outcomes:
measure: Usability
timeFrame: 2 years
Other outcomes:
measure: SADE Endpoint
timeFrame: 2 years
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Bat Yam
country: Israel
facility: Clalit Bat Yam
city: Be'er Sheva
country: Israel
facility: Clalit Be'er Sheva
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Bet Shemesh
country: Israel
facility: Clalit Bet Shemesh
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
Clinical trial NCT05279599: Application of Circulating Extracellular Vesicles in Early Disease Assessment and Prognosis After Traumatic Brain Injury
Official title: Application of Circulating Extracellular Vesicles in Early Disease Assessment and Prognosis After Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: molecular markers
prognosis
inflammation
peripheral circulation
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All TBI patients treated at Tangdu Hospital from January 2022 to December 2022

Brief summary: The purpose of this study was to observe the relationship between the changes of circulating extracellular vesicles and disease development and outcome in patients with traumatic brain injury, and to find early serum markers and potential intervention targets for disease monitoring in patients with traumatic brain injury. In addition, explore the source of extracellular vesicles as much as possible to prepare for subsequent basic experiments.

Detailed description: To compare the changes of molecular markers and circulating-related cell phenotype molecules in the serum of patients with traumatic brain injury, to observe the relationship between the changes of circulating extracellular vesicles and the development and outcome of the disease in patients with traumatic brain injury, and to search for early serum markers of patients with traumatic brain injury and potential interventions.

Eligibility criteria: Inclusion Criteria:

1. No systematic treatment before admission;
2. The patient is diagnosed with traumatic brain injury with imaging evidence;
3. Age \> 18 years old;
4. The patient or family members agree to sign the informed consent.

Exclusion Criteria:

1. Infectious diseases within the past 1 month;
2. Past head trauma, history of neurological diseases;
3. Non-isolated traumatic brain injury;
4. The patient is not receiving treatment in this hospital;
5. Severe disability, dementia, or organ dysfunction before the onset of the disease;
6. Subject refuses to participate.

Primary outcomes:
measure: The type and content of circulating extracellular vesicles
timeFrame: within 24 hours of TBI
measure: Neurological deterioration in patients with traumatic brain injury
timeFrame: within 7 days after injury
Secondary outcomes:
measure: hospital stay
timeFrame: From hospitalization to discharge，up to one month
measure: GOSE score
timeFrame: three months or six months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tandu Hospital, Fourth Military Medical University
Study officials:
affiliation: Tang-Du Hospital
name: Yan Qu, M.D, Ph.D
role: STUDY_CHAIR
affiliation: Tang-Du Hospital
name: Qing Hu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03715699: Leflunomide Treatment for IgG4-RD
Official title: Leflunomide Treatment for IgG4-RD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune Disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 70
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: This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Aged 18 to 70 years old with informed consent
* All patients must meet the following diagnostic criteria of IgG4RD (2011):

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L);
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
  4. exclusion of other diseases.

Exclusion Criteria:

* Patients will not be included if meets any of the following criteria:

  1. Patients who were diagnosed as other autoimmune diseases;
  2. Patients who were diagnosed as malignant diseases;
  3. Pregnant and lactating women；
  4. Active infection: HIV, HCV, HBV, TB；
  5. Serious organ function failure, expected life time less than 6 months.
  6. Presenting with Mikulicz disease without other manifestations.

Primary outcomes:
measure: Response of Leflunomide treatment for IgG4-RD
timeFrame: 1 year
Secondary outcomes:
measure: Relapse of Leflunomide treatment for IgG4-RD
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yunyun Fei
state: Beijing
Study officials:
References:
Clinical trial NCT04806399: Improving Utilization of Lung Cancer Screening in Underserved PA Populations
Official title: Improving Utilization of Lung Cancer Screening in Underserved PA Populations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Screening Utilization
Lead sponsor: American College of Radiology
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2021-03-19
Enrollment: 2500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly selected for assignment to the Outreach Contact with Decision Counseling Group or randomly selected for assignment to a Usual Care Control Group
Primary purpose: SCREENING

Brief summary: This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

Detailed description: The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.

Eligibility criteria: Inclusion Criteria:

* Have an upcoming office visit with a primary care physician in one of the study practices
* Between the ages of 50 and 77 (inclusive)
* History of smoking (current or former) in the electronic medical record (EMR)

Exclusion Criteria:

* Chest CT performed in the last 10 months before study initiation according to EMR
* Diagnosis of lung cancer indicated in the problem list in the EMR
* Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)

Primary outcomes:
measure: Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Health System
state: Pennsylvania
Study officials:
affiliation: American College of Radiology
name: Etta Pisano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jefferson Health System
name: Ronald Myers, PhD
role: STUDY_CHAIR
References: