louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01050348: To Investigate the Role of Upstream High Dose Statin in STEMI
Official title: A Double Blinded Randomized Placebo Controlled Study: To Investigate the Role of Upstream High Dose Statin Treatment in Patients With ST Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: The Western Pennsylvania Hospital
Sponsor class: OTHER
Collaborators: name: West Penn Allegheny Health System
First posted: 2010-01-15
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blinded randomized placebo controlled trial investigating the role of upstream 80mg Atorvastastin-calcium in patients undergoing percutaneous intervention for acute STEMI.


Eligibility criteria: Inclusion Criteria:

1. Any patient of 25 to 90 years of age admitted or transferred to Western Pennsylvania Hospital or Allegheny General Hospital with a diagnosis of STEMI undergoing emergent percutaneous intervention (PCI) to the culprit coronary artery. STEMI is defined as greater than 1mm ST segment elevation on electrocardiogram.
2. Elevated cardiac biomarkers (troponin-T \> 0.03ng/ml, CKMB\>5ng/mL, or ck\>170 U/l).

Exclusion Criteria:

1. Known history of liver disease defined as cirrhosis, alcoholic liver disease, Non alcoholic steatohepatitis, hepatitis or any causes of liver failure.
2. Renal failure with creatinine \>3mg/dL
3. Known history of liver or muscle disease such as rheumatologic myopathies, history of myositis, hepatitis, and hepatic cancer.
4. Cardiovascular arrest and shock.

Primary outcomes:
measure: Major adverse cardiovascular event (MACE) defined as cardiovascular death, MI, or target revascularization 30 days post percutaneous intervention.
timeFrame: 15 and 30 days post revascularization
Secondary outcomes:
measure: Any increase in mean peak values of CK-MB, troponin I and myoglobin greater than twice the upper limit after intervention.
timeFrame: 15 and 30 days post revascularization
measure: Any occurrence of major adverse cardiac events defined as death, MI, congestive heart failure, cardiogenic shock or need for unplanned revascularization within 24 hours after procedure or need for emergent CABG.
timeFrame: 15 and 30 days post revascularization
measure: Symptomatic side effects of current statin medication as described by adverse effects on consent form.
timeFrame: Immediately post revascularization to 30 days.
measure: Modified Coronary Revascularization Outcome Questionnaire (CROQ-PTCA)
timeFrame: 15 and 30 days post revascularization
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The Western Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Venkatraman Srinivasan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00206596: Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease
Official title: Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 127
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.

Detailed description: On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility criteria: Inclusion Criteria:

* You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening.
* You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease).
* You must be able to give yourself an injection of study drug or have another person help you give the injection.
* You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.

Exclusion Criteria:

* You may not be taking medications not allowed on this study.
* You may not have had GI surgery or bowel obstruction in the last 6 months.
* You may not have ever taken this drug or drugs of similar type in the past.

Primary outcomes:
measure: Corticosteroid-free remission
timeFrame: At the end of the study treatment
Secondary outcomes:
measure: Steroid-free remission or response to treatment as defined by the protocol
timeFrame: At the end of the study treatment
measure: Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)
timeFrame: At the end of the study treatment
Other outcomes:
Locations:
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Valentine JF, Fedorak RN, Feagan B, Fredlund P, Schmitt R, Ni P, Humphries TJ. Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study. Gut. 2009 Oct;58(10):1354-62. doi: 10.1136/gut.2008.165738. Epub 2009 Jun 7.
Clinical trial NCT06566196: A Study of Hemodynamic Cardiopulmonary Exercise for CHD
Official title: Invasive Hemodynamic Cardiopulmonary Exercise Testing for Assessment of Patients With Congenital Heart Disease (Cath CHD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between invasive hemodynamic assessments performed at rest versus exercise, to assess the correlation between invasive and noninvasive (Doppler-derived) rest-exercise hemodynamic indices and to compare the association between indices of disease severity and hemodynamic abnormalities identified at rest versus exercise.


Eligibility criteria: Inclusion Criteria:

* Congenital Heart Disease Diagnosis
* Undergoing Clinically indicated Cardiac Cath

Exclusion Criteria:

* Unable to consent
* Pregnancy

Primary outcomes:
measure: Change in left ventricular end-systolic elastance from rest to peak exercise
timeFrame: Baseline
measure: Change in Left ventricular cardiac output from rest to peak exercise
timeFrame: Baseline
measure: Change in systemic vascular resistance from rest to peak exercise
timeFrame: Baseline
measure: Change in right ventricular free-wall strain from rest to peak exercise
timeFrame: Baseline
measure: Change in right ventricular cardiac output from rest to peak exercise
timeFrame: Baseline
measure: Change in pulmonary vascular resistance from rest to peak exercise
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Egbe, M.B.B.S., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00307996: The Effect of CoQ10 Administration on Hemodialysis Patients
Official title: The Effect of CoQ10 Administration on the Oxidative and Antioxidative Markers in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Renal Failure
Hemodialysis
Keywords: CoQ10
hemodialysis
oxidative marker
antioxidant
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.

Detailed description: Oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. This study investigates whether CoQ10 administration is effective for protecting oxidative stress in hemodialysis patients. The subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.

Eligibility criteria: Inclusion Criteria:

* hemodialysis for at least 6 months

Exclusion Criteria:

* none

Primary outcomes:
measure: Oxidative protein concentration at 6 month
measure: Antioxidant capacity at 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Iwata
country: Japan
facility: Iwata City Hospital
state: Shizuoka
Study officials:
affiliation: University of Shizuoka
name: Hiromichi Kumagai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06165796: The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study
Official title: The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: Taipei Nobel Eye Clinic
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 331
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clear corneal phacoemulsification and IOL implantation were performed by single surgeon Chao-Kai Chang. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include only EDOF Symfony IOL (Johnson and Johnson, Santa Ana, CA, USA).

Brief summary: Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as difference between postoperative sphere and target refraction.


Eligibility criteria: Inclusion Criteria:

* presence of cataract in both eyes
* corrected distance visual acuity under 20/40
* Phacoemulsification cataract surgery was arranged for both eyes

Exclusion Criteria:

* complicated cataract
* corneal opacities or irregularities
* corneal astigmatism \> 1.50 diopter
* amblyopia, anisometropia
* surgical complications such as posterior capsular bag rupture or vitreous loss, IOL tilt or decentration
* coexisting ocular pathologies, glaucoma, non-dilating pupil, history of intraocular surgery, or retinopathy
* optic nerve or macular diseases
* refusal or unable to maintain follow-up.

Primary outcomes:
measure: visual acuity
timeFrame: 1 month after surgery
measure: refractive prediction error
timeFrame: 1 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Nobel Eye Clinic
Study officials:
References:
citation: Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19.
citation: Yeu E, Cuozzo S. Matching the Patient to the Intraocular Lens: Preoperative Considerations to Optimize Surgical Outcomes. Ophthalmology. 2021 Nov;128(11):e132-e141. doi: 10.1016/j.ophtha.2020.08.025. Epub 2020 Aug 31.
Clinical trial NCT01013896: Building Adherence to Live With And Navigate my Cystic Fibrosis (CF) Experience
Official title: Building Adherence to Live With And Navigate my CF Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-11-16
Enrollment: 128
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators research group and others have found that patient-reported adherence to all aspects of the regimen is suboptimal and objective measures suggest even poorer adherence. There is little data, however that identifies and examines the reason for nonadherence in an adult Cystic Fibrosis (CF) population or identifies effective strategies for improving adherence.

The investigators propose to evaluate the relative efficacy of a Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity compared to a CF education intervention (CFE; attention control group). Specifically, The investigators hypothesize that MI will result in improved regimen adherence and reduced CF morbidity compared to the CFE control group.


Eligibility criteria: Inclusion Criteria:

* Have a doctor confirmed diagnosis of CF
* Age 16 years old or older
* Prescribed an inhaled mucolytic, inhaled antibiotic therapy, chronic macrolide therapy and/or hypertonic saline therapy for the previous 12 months.
* Scheduled for a regular visit at either the pediatric or the adult CF clinic at Johns Hopkins Hospital.

Exclusion Criteria:

* Burkholderia cepacia complex isolated from the respiratory tract within the past 2 years.
* Had a lung transplant
* Participated in NA_00008649 A pilot study of Motivational Interviewing for adults with CF.

Primary outcomes:
measure: A medication possession ratio (MPR) will be calculated for each prescribed drug that is being monitored for adherence.
timeFrame: 12 months
Secondary outcomes:
measure: Change in Forced Expiratory Volume in One Second (FEV1) Percent Predicted.
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: The Johns Hopkins Adherence Research Center
name: Kristin A Riekert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755996: Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy
Official title: Combination of Dexmedetomidine Nasal Spray and Remifentanil for the Treatment of Pediatric Bronchoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fiberoptic Bronchoscopy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment

Detailed description: Dexmedetorimidine nasal spray is a new dosage form, which is simple and easy to achieve sedative and anti-anxiety effects by nasal spray mucosa. In the dose range from 50 to 100 μ g, the sedation effect increased dose-dependent, with\> 2 μ g / kg administered, and the child could be successfully separated within 45min.Our study is to observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment

Eligibility criteria: Inclusion Criteria:

* Age 2-6 years old (24\~72 months);
* ASA I-II;
* sign the informed consent.

Exclusion Criteria:

* Severe rhinitis, nasal deformity;
* abnormal liver and kidney function;
* severe dehydration, severe malnutrition, hypoproteinemia or anaemia Hb \<10 g/dl;
* children with neurological disease;
* history of allergy to the study drug;
* recent participation in other clinical studies.

Primary outcomes:
measure: Sedation success rate
timeFrame: 1day
Secondary outcomes:
measure: recoving time
timeFrame: 1day
measure: Drug dosage
timeFrame: 1day
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: pu zhou, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05311696: Residential Retreat for Veterans and First-responders
Official title: Examining the Efficacy and Feasibility of a Residential Retreat Program for PTSD in First-responders and Veterans: A Non-randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PTSD
Lead sponsor: Valhalla Project Niagara
Sponsor class: INDUSTRY
First posted: 2022-04-05
Enrollment: 70
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: These are individuals who are veterans of the military of first-responders, who have also been diagnosed with PTSD.

Brief summary: The purpose of this study is to determine the potential efficacy and feasibility of a residential retreat program to address PTSD symptoms in Veterans and First-responders

Detailed description: After obtaining written consent, participants will complete their program as they had previously intended. Each wave of the residential retreat program will last 5 days. During the program, participants will complete the study questionnaires. They will complete these questionnaires again 1 month after the completion of the program. As a control, individuals completing the program in the online format will also be asked to provide written consent and will complete the questionnaires during the program and 1-month after its completion.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD, being a military veteran or first-responder, awareness of treating physician about program attendance

Exclusion Criteria:

* None

Primary outcomes:
measure: Symptom Management of PTSD Using the Perceived Medical Condition Self-Management Scale
timeFrame: 1-month after completion of the program
measure: Drop-out rate in the Residential Program
timeFrame: at the end of the 5-day residential program for the residential cohort
measure: Symptoms of PTSD Indicated by the PTSD Checklist for DSM-5 scale.
timeFrame: 1-month after completion of the program
measure: Interpersonal and Intrapersonal Functioning Using the Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: 1-month after the completion of the program
measure: Drop-out rate in the Online Program
timeFrame: at the end of the 2 month online program for the online cohort.
Secondary outcomes:
Other outcomes:
Locations:
city: Niagara-on-the-lake
country: Canada
facility: Valhalla Project Niagara
state: Ontario
Study officials:
affiliation: Canadian Memorial Chiropractic College
name: Jaan Reitav, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05584696: Effectiveness of Green Color Exposure on Dental Anxiety
Official title: Effectiveness of Green Color Exposure on Dental Anxiety for Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety, Dental
Post Operative Pain
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator's aim in this study was to evaluate the preoperative anxiety and the pain felt during the operation due to exposure to green light. For this purpose, the participants will wear green or translucent glasses before the operation. The investigator will evaluate the patient's anxiety change and the pain she/he feels during the procedure.


Eligibility criteria: Inclusion Criteria:

* ASA 1 and ASA 2 patient population
* not having had a third molar surgery before
* volunteer to participate in the study

Exclusion Criteria:

* dental phobia
* patients who will be treated under general anesthesia
* refusing the measurements
* not filling the VAS

Primary outcomes:
measure: Pre-op Anxiety Score-1(VAS)
timeFrame: 1 minute after the participant enters the clinic
measure: Pre-op Anxiety Score-1(STAI-State)
timeFrame: 1 minute after the participant enters the clinic
measure: Pre-op Anxiety Score-2(VAS)
timeFrame: 10 minutes after the glasses put on
measure: Pre-op Anxiety Score-2(STAI-State)
timeFrame: 10 minutes after the glasses put on
measure: Pre-op blood pressure-1
timeFrame: 1 minute after the participant enters the clinic
measure: Pre-op blood pressure-2
timeFrame: 10 minutes after the glasses are put on
measure: Pre-op blood oxygen level-1
timeFrame: 1 minute after the participant enters the clinic
measure: Pre-op blood oxygen level-2
timeFrame: 10 minutes after the glasses are put on
measure: Pre-op Pulsation-1
timeFrame: 1 minute after the participant enters the clinic
measure: Pre-op Pulsation-2
timeFrame: 10 minutes after the glasses are put on and the patient sits in the chair
measure: Intraoperative Pain Score
timeFrame: 1 minutes after
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry
state: Selçuklu
Study officials:
affiliation: Selcuk University, Faculty of Dentistry
name: Gökhan Gürses
role: STUDY_CHAIR
References: