louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02218060: Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System
Official title: Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System: Diagnostic Performance and Potential for Reduction in Radiation Dose and Contrast Material Requirement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a patient is suspected of having coronary artery disease. The test, however, requires relatively high levels of radiation, which have been linked to DNA damage and cancer, and the use of contrast material, which can affect kidney function. The SOMATOM Force, a new third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds the potential to obtain quality images while also reducing radiation dose and contrast material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting coronary artery disease and also see if radiation dose and contrast material are reduced compared to the previous 2nd generation scanners. It is suspected that the Force will provide clinical quality images while decreasing radiation dose and contrast material required.


Eligibility criteria: Inclusion Criteria:

* Subject must be between 18-90 years of age.
* Subject must have been referred for a clinically indicated cardiac catheterization or nuclear cardiac perfusion study.
* Subject must provide written informed consent prior to any study-related procedures being performed.
* Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

* Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

  * By testing (urine βHCG) within 24 hours before contrast agent administration, or
  * By surgical sterilization, or
  * Post menopausal, with minimum one (1) year history without menses.
* Subject has an acute psychiatric disorder or is cognitively impaired.
* Subject is using or is dependent on substances of abuse.
* Subject is unwilling to comply with the requirements of the protocol.
* Subject has decreased renal function (eGFR \<45)
* Subject has an allergy against iodinated contrast agents.
* Subject is in acute unstable condition.

Primary outcomes:
measure: Radiation dose and contrast material
timeFrame: one year
Secondary outcomes:
measure: Diagnostic accuracy
timeFrame: one year
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC Ashley River Tower
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: U. Joseph Schoepf, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02249260: A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo
Official title: Long-term Follow up of Exercise Based Cardiac Rehabilitation in Oslo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Disease
Keywords: Exercise, cardiac rehabilitation, quality of life
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2014-09-25
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation.

Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.

Detailed description: A prospective cohort study including all cardiac patients referred for outpatient cardiac rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation. HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.

Eligibility criteria: Inclusion Criteria:

* stable coronary heart disease
* valvular surgery
* refered to high-intensity exercise training from a cardiologist

Exclusion Criteria:

* acute myocardial infarction within four week
* serious rhythm disturbances
* unstable angina pectoris
* known significant comorbidity
* symptomatic peripheral vascular disease
* obstructive pulmonary disease with forced expiratory vital capacity \< 60% of predicted
* left ventricular ejection fraction \< 40%

Primary outcomes:
measure: Change in peak oxygen uptake
timeFrame: baseline, 15 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: baseline, 12 weeks
measure: Peak oxygen uptake
timeFrame: baseline, 12 weeks
measure: Time to exhaustion
timeFrame: baseline, 15 months
measure: Time to exhaustion
timeFrame: baseline, 12 weeks
Other outcomes:
measure: Systolic and diastolic Blood Pressure
timeFrame: baseline, 12 weeks
Locations:
city: Oslo
country: Norway
facility: Norwegian Sport Clinic (NIMI)
Study officials:
affiliation: Oslo University Hospital
name: Birgitta B Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01648660: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation for Two More Years (LUTEGA 2)
Official title: Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients for Two More Years (LUTEGA 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Maculopathy
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective of LUTEGA 2 is it to determine the long term effect (about 2 more years after LUTEGA 1, NCT00763659) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids in two different dosages on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy. The dosage groups are crossed after LUTEGA 1.

Detailed description: The LUTEGA 2 is a cross-over- study and the continue of LUTEGA 1. After one year of supplementation in randomized, placebo- controlled, double blind study (LUTEGA 1), the treatment arms are unblind to cross over the different dosage groups.

The measurement of optical density of macular pigment (MPOD) uses the 1- wavelength reflection method recording reflection images at 480 nm by a fundus camera. The patients are followed up over two years in eight more visits (every three months) In addition to the MPOD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample (every six months).

Eligibility criteria: Inclusion Criteria:

* All non- exudative forms of age related maculopathy

Exclusion Criteria:

* Exudative age related maculopathy
* decrease opacity of ocular media

Primary outcomes:
measure: Optical density of macular pigment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Jena
name: Jürgen Strobel, MD
role: STUDY_DIRECTOR
affiliation: University of Leipzig
name: Jens Dawczynski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06303362: Effects of Elastic Band Excercises on Chest Expansion
Official title: Effects of Elastic Band Excercises on Chest Expansion in Patients With Forward Head Posture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forward Head Posture
Keywords: forward head posture
chest expansion
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: • To determine the effects of Elastic Band Exercises on Chest Expansion, Forward Head Posture and disability

Detailed description: According to literature review elastic band exercises have been proposed as an effective intervention to correct FHP. However, no previous study done to see the effect of elastic band exercises on chest expansion along with correction of FHP. Therefore, this study will show the effectiveness of elastic band exercises on chest expansion in patients with FHP.

Eligibility criteria: Inclusion Criteria:

1. Both genders
2. Age group Between 18 to 30 years
3. Forward head posture measured through craniovertebral angle less than 50 degrees
4. Chest expansion measurement values at axillary level less than 5.1 cm
5. MMT of upper limb greater than 4

Exclusion Criteria:

1. Any cardiopulmonary pathology
2. Recent rib fracture
3. Participants with other upper limb musculoskeletal pathologies
4. Spinal or any associated chest surgery

Primary outcomes:
measure: Cloth tape measurement
timeFrame: 4 weeks
measure: Neck Disability Index
timeFrame: 4 weeks
measure: Craniovertebral angle
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Railway hospital Rawalpindi
state: Punjab
Study officials:
affiliation: Riphah International University
name: Asmar Fatima, MS OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin G, Zhao X, Wang W, Wilkinson T. The relationship between forward head posture, postural control and gait: A systematic review. Gait Posture. 2022 Oct;98:316-329. doi: 10.1016/j.gaitpost.2022.10.008. Epub 2022 Oct 14.
citation: Balthillaya GM, Parsekar SS, Gangavelli R, Prabhu N, Bhat SN, Rao BK. Effectiveness of posture-correction interventions for mechanical neck pain and posture among people with forward head posture: protocol for a systematic review. BMJ Open. 2022 Mar 9;12(3):e054691. doi: 10.1136/bmjopen-2021-054691.
Clinical trial NCT06044662: Prognostic Value of Biomarkers in Polyneuropathy.
Official title: The Prognostic Value of Blood Biomarkers for Patients With Polyneuropathy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polyneuropathies
Keywords: polyneuropathy
biomarkers
cohort study
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 200
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 acquired or hereditary polyneuropathy (ICD-10 diagnosis) confirmed at nerveconduction study.

Brief summary: Biomarkers for prognosis of patients with polyneuropathy.

Detailed description: AIM: To investigate biomarkers' use as a prognostic tool in polyneuropathy patients.

STUDY DESIGN: Prospective cohort study of patients with polyneuropathy. METHODS: 200 patients with polyneuropathy will be examined with physical tests, medical examination, questionnaires, and blood biomarkers at baseline and at 1-year follow-up, and 2-year follow-up.

ANALYSIS: The investigators will calculate the odds of disease progression after 2 years depending on biomarkers levels at baseline using multiple logistic regression with sex and age adjustment. Diagnostic performance of the physical tests and biomarkers for prediction of disease progression will be assessed by Receiver Operating Characteristic Curve analysis with the area under the curve.

Eligibility criteria: Inclusion Criteria:

* Minimum 18 years old.
* Diagnosed with polyneuropathy, confirmed by nerve conduction study.
* Can read and understand Danish.

Exclusion Criteria:

* Inability to perform physical tests due to comorbidity not associated to the patient's polyneuropathy.

Primary outcomes:
measure: Disease Severity
timeFrame: 2 years
Secondary outcomes:
measure: Patient Reported Outcomes (PROMs)
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet
Study officials:
References:
Clinical trial NCT06113562: Close Obstructive Sleep Apnea (OSA) Trial
Official title: Patent Foramen Ovale Closure on Newly Diagnosed Patients With Obstructive Sleep Apnea and Refractory Hypoxia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Patent Foramen Ovale
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the benefits of patent foramen ovale (PFO) closure on patients with obstructive sleep apnea (OSA) and persistent hypoxia despite optimal therapy.


Eligibility criteria: Inclusion Criteria:

1. Individuals diagnosed with severe OSA, defined as an apnea-hypopnea index (AHI) greater than 30, associated with nocturnal saturation below 90%, as determined by a sleep medicine specialist using polysomnography.
2. Individuals need to have a patent foramen ovale documented by echocardiography.

Exclusion Criteria:

1. Individuals unable to take aspirin, clopidogrel, and/or ticagrelor.
2. Pregnant individuals or those who become pregnant during the course of the study will be automatically withdrawn.

Primary outcomes:
measure: changes in the apnea hypoxia index
timeFrame: baseline and then up to 3 months after the study
measure: change in mean nocturnal oxygen saturation
timeFrame: baseline and then up to 3 months after the study
measure: change in duration of nocturnal oxygen desaturation duration.
timeFrame: baseline and then up to 3 months after the study
Secondary outcomes:
measure: change in quality of life as measured by the patient global impression of change scale.
timeFrame: baseline and then up to 3 months after the study
measure: change in quality of sleep as measured by the Epworth Sleepiness Scale
timeFrame: baseline and then up to 3 months after the study
measure: Change in physical activity as measured by Godin Leisure time physical activity questionnaire.
timeFrame: baseline and then up to 3 months after the study
measure: change in fatigue as measured by the Fatigue Severity Scale.
timeFrame: baseline and then up to 3 months after the study
measure: changes in functional independence measure
timeFrame: baseline and then up to 3 months after the study
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Eduardo de Marchena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03312491: Treatment of Acetabular Fracture: the Contribution of the 3D Impression
Official title: Treatment of Acetabular Fracture: the Contribution of the 3D Impression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fracture
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient admitted in orthopaedic yard for acetabulum fracture

Brief summary: Acetabular fracture are common in elder patients and high energy trauma in younger one.

However, the fracture deplacement induces incongruity between cotyloid cavity and femoral head. Anatomic reduction and osteosynthesis of these fracture are technically difficult .

3D printing ease the process of operating planification or implant fabrication. The 3D impression allows to obtain a model on the scale of the pond of the patient allowing to pre mold plates on the anatomy of the patient before he is operated with the aim of decreasing the surgical time and improving the quality of the reduction.


Eligibility criteria: Inclusion Criteria:

* age \>18
* acetabulum fracture within one month
* anterior access or double access

Exclusion Criteria:

* acetabulum fracture more than one month

Primary outcomes:
measure: operating room time
timeFrame: day1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: Pomme JOUFFROY, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03204591: Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury
Official title: Risk of Bacterial Infection in Cirrhotic Patients With Acute Severe Liver Injury: a Multicenter,Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis, Liver
Bacterial Infections
Acute Liver Injury
Lead sponsor: The Zhejiang Study Group for Organ Failure in Cirrhosis
Sponsor class: OTHER
Collaborators: name: Ningbo No.2 Hospital
First posted: 2017-07-02
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis of any etiology who had acute severe liver injury

Brief summary: Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.


Eligibility criteria: Inclusion Criteria:

1. The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
2. Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin \>=85mmol/L and international normalized ratio (INR)\>=1.5 with a definite hepatic insult.

Exclusion Criteria:

(1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;

Primary outcomes:
measure: Occurrence of bacterial infection
timeFrame: Within 3 months from admission
Secondary outcomes:
measure: 28-day Mortality
timeFrame: Within 28 days after enrollment
measure: 90-day Mortality
timeFrame: Within 90 days after enrollment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of infectious disease, First Affiliated Hospital of Zhejiang University
name: Jifang Sheng, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT03961191: DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study
Official title: Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DNA Methylation
Uterine Cervical Cancer
High Grade Squamous Intraepithelial Lesions
Low Grade Squamous Intraepithelial Lesions
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Wtih confirmed cervical histology within one month when collecting cervical cytology
2. Aged 18 years or older

Brief summary: The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions.

This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.


Eligibility criteria: Inclusion Criteria:

* Confirmed cervical histology within one month when collecting cervical cytology
* Aged 18 years or older
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting any of the inclusion criteria

Primary outcomes:
measure: Sensitivity of DNA methylation
timeFrame: 1 years
measure: Specificity of DNA methylation
timeFrame: 1 years
Secondary outcomes:
measure: Positive predictive value of DNA methylation
timeFrame: 1 year
measure: Negative predictive value of DNA methylation
timeFrame: 1 year
measure: Correlation coefficient of DNA methylation with other screening methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: