louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00610870: Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention
Official title: Effect of Atorvastatin Administration Before Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Myocardial infarct size
Atorvastatin
SPECT
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to determine whether statin pretreatment decrease myocardial infarct size in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* Presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
* ST segment elevation more than 1 mm in two or more contiguous leads or presumably a new onset left bundle branch blockage

Exclusion Criteria:

* Cardiogenic shock
* History of myocardial infarction
* Chronic liver disease
* Previous or current statin use

Primary outcomes:
measure: Myocardial infarct size by SPECT
timeFrame: between 5 and 14 days after acute myocardial infarction
Secondary outcomes:
measure: Myocardial infarct size measured by contrast-enhanced MRI
timeFrame: within 14 days after acute myocardial infarction
measure: Myocardial blush grade after the procedure
timeFrame: immediate after procedure
measure: complete ST resolution
timeFrame: at 60 minutes after the procedure
measure: major adverse cardiac events related to left ventricular dysfunction (death, new-onset sustained hypotension or heart failure, and hospital readmission for left ventricular dysfunction)
timeFrame: at 6 months after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218970: The Effect of Muscular Strength Training in Patients With Drug Addiction
Official title: The Effect of Muscular Strength Training in Patients With Drug Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-related Disorders
Keywords: rehabilitation
strength training
muscle strength
physical fitness
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical health does not have a high priority in today's treatment of patients with substance use disorder (SUD). SUD patients have a poor physical health not only due to injuries related to the substance abuse, but also because of the addiction-related lifestyle. There are few studies today that provide information about SUD patient's physical health, and especially there is little information about their muscular strength. One of the project's aims is to measure muscular strength in SUD patients who are being treated for their addiction, and see if they have decreased neuromuscular function. If so, we will investigate the effect of maximal strength training on neuromuscular function in these patients.


Eligibility criteria: Inclusion Criteria:

* being treated for drug abuse
* not using drugs during intervention period

Exclusion Criteria:

* participated in strength training in previous 6 months
* cardiovascular disease
* any other disease that impedes to finish tests
* not showing up for testing sessions
* carried out less than 85% of planned exercise sessions

Primary outcomes:
measure: muscle strength
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Rusbehandling Midt-Norge H
Study officials:
affiliation: Norwegian University of Science and Technology
name: Grete Flemmen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unhjem R, Flemmen G, Hoff J, Wang E. Maximal strength training as physical rehabilitation for patients with substance use disorder; a randomized controlled trial. BMC Sports Sci Med Rehabil. 2016 Mar 31;8:7. doi: 10.1186/s13102-016-0032-2. eCollection 2016.
Clinical trial NCT05319470: Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives
Official title: Ocular Surface Disease and IOP Monitoring With Travoprost Without Conservatives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Glaucoma; Drugs
Ocular Surface Disease
Keywords: glaucoma
travoprost
prostaglandin without preservatives
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult glaucoma patients already under treatment with travoprost without preservatives.

Brief summary: Primary objective of this study is to study the efficacy of travoprost without preservatives in the treatment of glaucoma patients and to monitor the ocular surface.

Detailed description: This is a prospective study including patients visiting the outpatient glaucoma clinic of the University General Hospital of Alexandroupolis for their standard evaluation. Study population is already under treatment with a travoprost preparation without preservatives. They will be fully informed about the procedure and the purpose of the study and a written consent will be obtained. For every patient included in the study intraocular pressure will be measured using a Goldman applanation tonometer, according to the standard way of practice at our clinic. Also, Tear Break-Up-Time (BUT), conjunctival hyperemia grading and Schirmer testing will be used to assess the ocular surface state. Visual field tests and OCT RNFL measurements will also be obtained. The above measurements will be repeated 6 months after the initial examination.

Eligibility criteria: Inclusion Criteria:

* Patients with glaucoma treated with travoprost without preservatives.

Exclusion Criteria:

* Co-administration of another anti-glaucoma preparation with or without preservatives, Sjogren's syndrome, poor eyelid occlusion of any etiology.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 6 months
measure: Ocular Surface Disease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
name: Georgios Labiris, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01332370: Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone
Official title: Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Keywords: Retrospective
Type 2 Diabetes
Cost Analysis
Rosiglitazone
Sitagliptin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 5391
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults continuously enrolled in a large US health insurance plan with a diagnosis of diabetes who are currently receiving Metformin

Brief summary: This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.


Eligibility criteria: Inclusion Criteria:

* Continuously enrolled in the health insurance plan to ensure complete claims coverage
* At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
* Aged 18 years or older at the index date
* At least 6 months of baseline period prior to the index date
* At least 1 claim for MET during the baseline period
* At least 180 days of continuous therapy with RSG+MET or STG+MET after the index date

Exclusion Criteria:

* At least 1 claim for insulin or sulfonylurea in the baseline period
* At least 1 claim with a diagnosis of congestive heart failure in the baseline period

Primary outcomes:
measure: medical resource utilization
timeFrame: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01201070: Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Official title: Effects of the Administration Of Antithrombin on the Coagulation Status and on the Inflammatory Response in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Aortic Valve Insufficiency
Aortic Valve Stenosis
Mitral Valve Insufficiency
Mitral Valve Stenosis
Acute Coronary Syndrome
Lead sponsor: University of Bari
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative Antithrombin (AT).


Eligibility criteria: Inclusion Criteria:

* All patients were candidates for cardiac surgery intervention in extracorporeal circulation

Exclusion Criteria:

* positive history for allergic reactions to AT III
* cardiac surgery "Off-Pump"
* administration of AT during surgery or within 48 h
* treatment with drugs and non-steroidal steroids within 48 h prior
* disorders of coagulation
* platelets \<30,000
* pre-existing IRC in dialysis treatment
* severe liver failure
* enlistment in another trial in the last 30 days
* hypothermia
* emergency
* reopening
* length of CEC\> 180 minutes
* subjects incapable of giving legal consent

Primary outcomes:
measure: Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
timeFrame: until 5 days after surgey
Secondary outcomes:
measure: Number of participants with infection as a measure of safety.
timeFrame: until 5 days after surgery
measure: Number of participants with delirium as a measure of safety.
timeFrame: until 5 days after surgery
measure: Number of participants with wound complication as a measure of safety.
timeFrame: until 5 days after surgery
measure: Number of participants with multi organ failure as a measure of safety.
timeFrame: until 5 days after surgery
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico
Study officials:
affiliation: Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
name: Domenico Paparella, Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03932370: Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones
Official title: Flexible Ureteroscopy Versus Mini-Percutaneous Nephrolithotomy for Treatment of Renal Stones 2 Cm or Less; A Randomised, Comparative Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stone;Renal
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: no specific criteria

Brief summary: Management of nephrolithiasis is evolving rapidly, and various minimally-invasive urological procedures are currently available for treating patients with renal stones, including extracorporeal shockwave lithotripsy (ESWL), flexible ureteroscopy (f-URS) and miniaturised percutaneous nephrolithotomy (mini-PCNL).

Despite being the only truly-non-invasive, outpatient procedure, stone-free rates (SFRs) of ESWL are lower than both mini-PCNL and f-URS. Furthermore, ESWL has several limitations, such as pregnancy; uncorrected coagulopathy;aortic aneurism; severe obesity; large stone burdens (\>2cm); stones with high densities (\>970/1000 Hounsfield units); ESWL-resistant stone compositions; lower calyceal stones with unfavourable anatomical criteria; and stones in calyceal diverticula; Morbidities of the conventional PCNL are significantly minimised by using less access diameters in PCNL while providing comparable SFRs. Additionally, Mini and Micro PCNL result in shorter hospital stay and higher tubeless rates compared to conventional PCNL.

Flexible ureteroscopy has been increasingly used as a primary modality for treatment of renal stones with significantly lower complication rates than PCNL and mini-PCNL in terms of less bleeding and transfusion rates, shorter hospital stay and less postoperative pain. Additionally, f-URS is the only treatment modality of nephrolithiasis that can be safely and effectively used in patients with bleeding tendency, as well as pregnant women; moreover, its outcomes are not affected by obesity. Nevertheless, its poor durability and high costs remain major limitations for f-URS, especially in developing countries.


Eligibility criteria: Inclusion Criteria:

1. Age above than 15 years
2. Renal stone(s) with total burden of 2 cm or less
3. Signature on written, informed consents with the details of this study requirements.
4. Inappropriateness or failure of ESWL (examples of ESWL inappropriateness: patient preference; distal obstruction; contraindications of ESWL)

Exclusion Criteria:

1- asymptomatic bacteruria 2- active urinary tract infection (UTI) 3- uncorrected coagulopathy 4- current use of antiplatelet therapy 5- pregnancy

-

Primary outcomes:
measure: stone clerance
timeFrame: postoperative within the first 24 hours
measure: Haemoglobin drop
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06923670: Prevalence Of Germline Gene Mutations In Patients With Myeloproliferative Neoplasms With Family History
Official title: Prevalence Of Germline Gene Mutations In Patients With Myeloproliferative Neoplasms With Family History
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycythemia Vera
Essential Thrombocythaemia
Myelofibrosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Philadelphia-negative myeloproliferative neoplasms (MPNs) occur sporadically and are due to somatic mutations in the JAK2 (Janus kinase 2), CALR (calreticulin) and MPL (thrombopoietin receptor) genes. However, data from epidemiological and family studies clearly highlight a heritable component that influences the risk of developing MPN and potentially contributes to the observed phenotypic pleiotropy. Genome-wide association studies in MPN familial clusters have identified a number of germline genetic variants associated with an increased risk of developing MPN. The strongest association discovered so far is the presence of the JAK2 46/1 haplotype and, subsequently, several studies have found additional variants in other genes, particularly in the TERT gene.

The aim of the study would be to investigate the presence of germline mutations in MPN patients selected on the basis of a family history of myeloid neoplasms through the analysis of both already recognized genes and other potentially implicated ones.


Eligibility criteria: Inclusion Criteria:

\*Patients \>18 years

* Diagnosis of MPN (Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis) confirmed according to ICC 2022 criteria
* Familiarity for myeloid neoplasia: at least one first or second degree relative affected by myeloid neoplasia (probands) OR presence of matching criteria with a proband (controls). Each center will be able to contribute with its own available patients/relatives, providing the clinical-laboratory data required by the study.

  * Signing of informed consent according to ICH/EU/GCP and local national laws (if applicable)

Exclusion Criteria:

* Patients \<18 years Patients with other hematological diagnoses; • Lack of informed consen

Primary outcomes:
measure: Comparison between clinical characteristis in patients with and without family history:
timeFrame: 30 months
measure: Comparison between biological characteristis in patients with and without family history:
timeFrame: 30 months
Secondary outcomes:
measure: Prevalence of germline mutations in MPN patients
timeFrame: 36 months
measure: Distribution of hematologic malignancies in the group with familial hystory
timeFrame: 36
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02389270: Urinary Neurotrophin Levels in Healthy Children
Official title: Age and Daytime Variations in Urinary Neurotrophin Levels in Healthy Children Without Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder
Keywords: Neurotrophins
Nerve Growth Factor
Brain-Derived Neurotrophic Factor
Urinary Biomarkers
Children
Lead sponsor: Children's Hospital Zagreb
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will include a group of healthy children recruited from a primary care clinic.

Brief summary: The aim of this study is to analyse urinary neurotrophin levels in healthy children. Urine samples will be collected at 3 different times of day (morning, noon, and evening) at urge sensation from all age groups of children who gained bladder control, i.e. from 3-18 years of age. Urinary levels of nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinine will be analysed. Age and daytime related variations will be reported for both boys and girls. These results will contribute to understanding the role of neurotrophins in the physiology of lower urinary tract and pathophysiology of idiopathic and secondary hyperactive bladder in children.


Eligibility criteria: Inclusion Criteria:

* 3-18 years of age
* a unremarkable clinical examination
* a normal voiding pattern
* a minimum of 3 micturitions per day
* informed oral and written consent from the child and both parents/legal guardian

Exclusion Criteria:

* history of urinary tract infection
* diseases of central or peripheral nerve system
* anomalies of lumbosacral region
* chronic diseases
* operative procedures or anomalies of urinary or genital tract
* lower urinary tract symptoms
* constipation
* hypercalcuria
* urolithiasis, depression, eating disorders or cardio-metabolic diseases
* prior use of anticholinergic treatment

Primary outcomes:
measure: Concentration of urinary nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) normalised to urinary creatinin
timeFrame: Collection of urine samples and analysis will take approximately 6 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Zagreb
name: Slaven Abdovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03942770: Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2
Official title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-05-08
Enrollment: 230
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: Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.


Eligibility criteria: Inclusion Criteria:

* Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic or University of Kentucky Healthcare system.
* Meet DSM-V criteria for alcohol use disorder.
* Abstinent from alcohol at the time of consent.

Exclusion Criteria:

* Alcohol use disorder is secondary to another substance use disorder.

Primary outcomes:
measure: Pattern of abstinence from alcohol during intervention
timeFrame: up to 66 weeks
measure: Treatment acceptability
timeFrame: A total of 12 assessment sessions spanning over a 66 week period
measure: Time to relapse
timeFrame: A total of 12 assessment sessions spanning over a 66 week period
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Healthcare
state: Kentucky
city: Roanoke
country: United States
facility: Virginia Tech Carilion
state: Virginia
Study officials:
References: