louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02779946: Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease
Official title: Non-invasive Liver Screening for Risk Assessment for Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Non-alcoholic Fatty Liver Disease
Elasticity Imaging Techniques
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Leipzig
First posted: 2016-05-23
Enrollment: 216
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 presenting for routine angiography of coronary vessles to the Division of cardiology and angiography of the University Hospital Leipzig

Brief summary: Background: Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of the metabolic syndrome, which is one of the major risk factors of coronary heart disease (CHD). CHD is the most important manifestation of atherosclerosis, because of its immense morbidity and mortality. Transient elastography (TE, Fibroscan®) including the currently developed controlled attenuation parameter (CAP) is a non-invasive method for evaluation of liver fibrosis and steatosis, which is already implemented in routine care of patients with NAFLD. Hypothesis: The use of TE with CAP as screening for NAFLD might be an easy tool for risk assessment for CHD. Methods: Patients scheduled for routine coronary angiography will be screened for manifestation of NAFLD by TE including CAP, conventional ultrasound, clinical and laboratory parameters. Patients will be stratified for the presence of CHD based on the angiography results and correlation analysis with liver fat content will be performed. NFALD screening will be validated in a subgroup by MR-based measurements.


Eligibility criteria: Inclusion Criteria:

* informed consent
* age ≥ 18 years
* patients with indication for routine coronary angiography

Exclusion Criteria:

* transplanted liver
* resection of right liver lobe
* transaminases of \> 5-fold upper limit
* pregnancy or lactation
* choleastasis on ultrasound imaging
* active malignant or consuming disease 12 month before inclusion
* congestive heart failure (EF\<30%, NYHA III or IV, diastolic dysfunction °III or IV
* pulmonary hypertension (WHO °III or IV) Exclusion criteria for MR diagnostics
* pacemaker or ICD
* non removable magnetizable metal implants
* claustrophobia

Primary outcomes:
measure: Correlation of presence CHD and NAFLD
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of severity of CHD and NAFLD
timeFrame: 1 year
measure: Fibrocan vs MR-based methods
timeFrame: 1 year
measure: Correlation of NAFLD and intima media thickness
timeFrame: 1 year
measure: Correlation of NAFLD and other signs of atherosclerosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig University Medical Center
Study officials:
affiliation: Leipzig University Medical Center, IFB AdiposityDiseases
name: Sebastian Beer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00654446: IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin
Official title: A 6-wk Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study, Which Describes the Renal Effects of the Lipid-Regulating Agents Rosuvastatin and Simvastatin in the Treatment of Sub's With Fredrickson Type IIa & Type IIb Dyslipidaemia, Inc. Heterozygous Familial Hypercholesterolaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fredrickson Type IIa & Type IIb Dyslipidaemia
Keywords: Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Simvastatin
Zocor
Renal
kidney
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 442
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: The purpose of this study is to assess the effects on the kidney of rosuvastatin and simvastatin in subjects with Fredrickson Type IIa \& Type IIb Dyslipidaemia


Eligibility criteria: Inclusion Criteria:

* Fasting low density lipoprotein level as defined by the protocol.
* Fasting triglyceride level as defined by the protocol.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood creatine levels above the limits defined in the protocol or +4 proteinuria during dietary lead in period.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Primary outcomes:
measure: Development of Proteinuria
timeFrame: 2 weekly
Secondary outcomes:
measure: Renal effects of rosuvastatin and simvastatin
timeFrame: 2 weekly
measure: Low density lipoproteins cholesterol levels
timeFrame: 2 weekly
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: 2 weekly
Other outcomes:
Locations:
Study officials:
affiliation: Metabolic & Athersclerotic research centre, Cincinatti, USA
name: Evan Stein
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT03944746: Assessment of an Orthopedic Surgery Rotation on Musculoskeletal Competency in Emergency Medicine Residency Training
Official title: Assessment of an Orthopedic Surgery Rotation on Musculoskeletal Competency in Emergency Medicine Residency Training
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Educational Problems
Orthopedic Disorder
Emergencies
Keywords: Emergency Department Education
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
First posted: 2019-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is whoever is an emergency medicine resident at the programs listed previously.

Brief summary: Patient commonly present with orthopedic injuries in the emergency department. Musculoskeletal education has not historically been emphasized in American medical schools, and the effectiveness of an orthopedic surgery rotation has not been well studied in emergency medicine (EM) training. Competency in musculoskeletal education has been tested previously with a validated instrument, the basic competency exam (BCE), to assess baseline knowledge in primary care and emergency physicians.

Residents from 2 different EM residency training programs will be given the BCE to determine baseline musculoskeletal knowledge prior to their orthopedic surgery rotations. A post-test BCE will be given to the residents from both EM training programs upon completion of their orthopedic surgery rotation and compared.


Eligibility criteria: Inclusion Criteria:

* Emergency Medicine Residents at either San Antonio Military Medical Center or University Hospital

Exclusion Criteria:

* Not emergency medicine residents at the inclusion sites.

Primary outcomes:
measure: Change in performance on the orthopedic basic competency exam
timeFrame: Assessed initially by taking the exam before completing a one month orthopedic rotation. The same exam is taken at the completion of the orthopedic rotation. The two test results are compared to each other between each individual and residency program.
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT06848946: Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone
Official title: Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Glaucoma, Open-angle
Ocular Hypertension (OHT)
Phacoemulsification Cataract Surgery
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2025-02-27
Enrollment: 132
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone

Detailed description: This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Eligibility criteria: Inclusion Criteria:

* Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
* OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion Criteria:

* Active corneal inflammation or edema.
* Retinal disorders not associated with glaucoma.

Primary outcomes:
measure: Change from baseline in mean diurnal IOP
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kenosha
country: United States
facility: Glaukos Investigator Site
state: Wisconsin
Study officials:
affiliation: Glaukos Corporation
name: Luis Vargas
role: STUDY_CHAIR
References:
Clinical trial NCT00127946: Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
Official title: Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastroschisis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-08-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted at the level of the abdominal hole. The bowel is therefore submitted to different injuries partly attributable to the contact with amniotic fluid contaminated by digestive compounds and inducing an inflammatory reaction. Experimental studies on animal models and preliminary data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would improve the outcome of theses fetuses and then neonates.

Detailed description: Primary Objective: To compare prospectively the effect of AMNIOECHANGE against classical care on the delay of full enteral feeding in gastroschisis affected foetuses

Study:

* Multicenter, Randomized.
* Inclusion at 20 GA (gestational age) weeks.
* AMNIOECHANGE every 2 weeks from 30 GA weeks

Subject: 140 inclusion during 3 years

Analysis: Triangular Sequential Evaluation

Eligibility criteria: Inclusion Criteria:

* Seen before 30 GA weeks
* Normal karyotype
* Single pregnancy
* Isolated gastroschisis
* No associated disease (maternal)
* Accept randomization and understand the study

Exclusion Criteria:

* Maternal diabetes
* Maternal infection with HIV, hepatitis
* Preexistent oligohydramnios before inclusion

Primary outcomes:
measure: Duration of ventilation in the ICU and the duration of parenteral nutrition
timeFrame: 7 days and 45 days after the birth of the child
Secondary outcomes:
measure: Evaluation of the contribution of iterative AMNIOECHANGE
timeFrame: 7 days, 45 days, 12 months and 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre hospital, AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique Luton, MD, PhD
role: STUDY_CHAIR
References:
citation: Luton D, Mitanchez D, Winer N, Muller F, Gallot D, Perrotin F, Jouannic JM, Bretelle F, de Lagausie P, Ville Y, Guibourdenche J, Oury JF, Alberti C, Benachi A. A randomised controlled trial of amnioexchange for fetal gastroschisis. BJOG. 2019 Sep;126(10):1233-1241. doi: 10.1111/1471-0528.15804. Epub 2019 May 20.
Clinical trial NCT01946646: Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer
Official title: A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Pancreatic Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: TTY Biopharm
First posted: 2013-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
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 determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma
* no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer
* presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan
* age between 20 and 79 years at registration
* ECOG PS of 0 or 1
* adequate major organ functions
* ability to take the oral study medication (TS-1)
* no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
* voluntarily signed the written informed consent form

Exclusion Criteria:

* pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
* presence of diarrhea ≥ CTCAE v.4.03 grade 2
* concomitant active infection or significant co-morbid medical conditions
* moderate or severe ascites or pleural effusion that requires drainage
* central nervous system metastasis
* prior or concurrent malignancies within the last 3 years
* concomitant treatment with flucytosine, phenytoin or warfarin
* pregnant women or nursing mothers, or positive pregnancy test
* severe mental disorder
* judged ineligible by physician for participation in the study due to safety concern

Primary outcomes:
measure: maximum tolerated dose
timeFrame: 6 weeks
measure: maximum-tolerated dose
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT06674746: Effect of Solution-Focused Approach on the Internet,Social Media Addiction and Self-Efficacy Levels OfNursing Students
Official title: The Effect of Solution-Focused Approach on the Internet, Social Media Addiction and Self-Efficacy Levels of Nursing Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Social Media Addiction
Internet Addiction
Keywords: solution focused approach
nursing
internet addiction
social media addiction
self-efficacy-sufficiency
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research; is to determine the effect of solution-oriented approach on internet, social media addiction and self-efficacy levels of nursing students.

A pretest-posttest randomized controlled experimental design will be used in the research.

Detailed description: The research will be carried out between 4 April 2022 and 28 April 2023 at Sivas Cumhuriyet University . Personal Information Form, Internet Addiction Scale, Social Media Addiction Scale and Self-Efficacy Competence Scale were applied to a total of 1057 nursing students who were continuing their education in the 1st, 2nd and 3rd years at the Faculty of Health Sciences (683) and Suşehri Health College (374), where the research would be conducted.Since the final data of the study will be received next year, students in the 1st, 2nd and 3rd grades will be included in the interviews in order to prevent data loss, and 4th graders will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-25,
* 67 \< Internet Addiction Scale (IAS) Score \< 109,
* 73 \< Social Media Addiction (SMDS) Score \< 140.

Exclusion Criteria:

* Receiving any psychological counseling and treatment,
* Being closed to communication,
* To have extended the term,
* Not volunteering to participate in the research.

Primary outcomes:
measure: Internet Addiction Scale
timeFrame: 10 minute
measure: Social Media Addiction Scale
timeFrame: 10 minute
measure: Self-Efficacy-Efficacy Scale
timeFrame: 5 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cumhuriyet University
name: Taha Mert, postgraduate
role: STUDY_DIRECTOR
affiliation: Cumhuriyet University
name: Nuran Güler, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01466946: Understanding Symptom Recognition and Treatment Decision-making in Hispanic/Latino Lung Cancer Patients
Official title: Understanding Symptom Recognition and Treatment Decision-making in Hispanic/Latino Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: lung cancer
Hispanic/Latino patients
interviews
11-109
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The Sophie Davis School of Biomedical Education The City College of New York
name: City University of New York
First posted: 2011-11-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC.

Brief summary: The purpose of the study is to understand why Hispanic/Latino patients with lung cancer are diagnosed later than other groups.


Eligibility criteria: Inclusion Criteria:

* Self-identified Hispanic/Latino patients with biopsy-proven primary lung cancer treated at MSKCC, including stages of disease I-IV
* 18 years of age or older
* Fluent in English or Spanish
* Patients must reside in the U.S

Exclusion Criteria:

* Spanish-surnamed patients who do not self identify as Hispanic/Latino (e.g., Philippines-born individuals)

Primary outcomes:
measure: psychosocial issues
timeFrame: 2 years
measure: cultural issues
timeFrame: 2 years
Secondary outcomes:
measure: identify obstacles
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Alago, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00328146: Re-operative Surgery in Children:A Technique for Sternal Re-Entry
Official title: Re-operative Surgery in Children: A Technique for Sternal Re-Entry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
re-operative surgery
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 802
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any child undergoing re-operative cardiac surgery through a midline sternotomy incision. This is a chart review.

Brief summary: Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Detailed description: Background Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Methods This will be primarily a technique paper. The only clinical data points I am interested in are how many re-operative sternotomies we performed and on how many patients. I will also need to confirm that we did not have any complications due to cardiac injury while opening the sternum. I estimate about 450 patients.

Primary Aim: Present an effective technique for sternal re-entry in children

Secondary Aim: Present a zero incidence of complicated sternal re-entry over the past 5 years (February 1, 2001 through February 28, 2006) at Children's Healthcare of Atlanta, Egleston Hospital.

Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Eligibility criteria: Inclusion Criteria:

* Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Exclusion Criteria:

* Those who do not fall under the above inclusion criteria

Primary outcomes:
measure: Present an effective techniqe for sternal re-entry in children.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Brian E Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References: