louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01809743: Regadenoson and Adenosine
Official title: Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Regadenoson
Adenosine
Maximal hyperemia
Fractional flow reserve
FFR
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 100
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: DIAGNOSTIC

Brief summary: The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard)and to investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery

Exclusion Criteria:

* Severe aortic valve stenosis
* History of severe COPD
* Syncope or bradycardia (less than 50 beats/min)
* Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)
* Severe hypotension (RR \<90 mmHg)
* Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic
* Coronary anatomy not suitable for FFR measurement (extremely tortuous or calcified coronary vessels)
* Previous coronary bypass surgery
* Recent ST elevation myocardial infarction (\<5 days)
* Recent non-ST elevation myocardial infarction (\<5 days) if the peak CK is \>1000 IU
* Inability to provide informed consent
* Pregnancy
* Use of methylxanthines (in the last 12 hours)
* Use of Dipyridamol (in the last 48 hours)

Primary outcomes:
measure: the accuracy of Regadenoson to induce maximal and steady state hyperemia
timeFrame: participants will be followed up during hospital stay, an expected average of 1 day
Secondary outcomes:
measure: time intervals of maximum hyperemia
timeFrame: participants will be followed up during hospital stay, an expected average of 1 day
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Nico H.J. Pijls, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: Lokien X van Nunen, MD
role: STUDY_DIRECTOR
References:
citation: van Nunen LX, Lenders GD, Schampaert S, van 't Veer M, Wijnbergen I, Brueren GR, Tonino PA, Pijls NH. Single bolus intravenous regadenoson injection versus central venous infusion of adenosine for maximum coronary hyperaemia in fractional flow reserve measurement. EuroIntervention. 2015 Dec;11(8):905-13. doi: 10.4244/EIJY14M08_10.
Clinical trial NCT05475743: Pain Informed Movement Program in Patients With Post COVID-19 Condition
Official title: Early Effects of a Pain Informed Movement Program in Patients With Post COVID-19 Condition Experiencing Persistent Pain: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19 Condition
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 60
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: Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of Pain Informed Movement program in patients with post COVID-19 condition experiencing persistent pain. Through the implementation of this program, the investigators seek to determine whether such intervention can offer significant improvements in reducing pain intensity and interference, catastrophizing, kinesiophobia, and functionality of affected patients.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes.
* Agreed to participate.
* Post COVID-19 condition patients meeting the WHO definition for this disease.
* Patients with moderate or severe pain were included, the cut-off point on the Visual Analogical Scale (VAS) being pain greater than or equal to 3.5 cm.

Exclusion Criteria:

* Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients suffering from a reinfection with SARS-CoV-2.
* Patients with a history of severe or critical COVID-19 disease severity.
* Patients who had pre-existing chronic pain according to the current IASP definition.
* Patients participating in other studies.

Primary outcomes:
measure: Changes in pain intensity and pain interference
timeFrame: Baseline and at 8 weeks at the end of the intervention
measure: Changes in catastrophization
timeFrame: Baseline and at 8 weeks at the end of the intervention
measure: Changes in kinesiophobia
timeFrame: Baseline and at 8 weeks at the end of the intervention
measure: Changes in functionality
timeFrame: Baseline and at 8 weeks at the end of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Granada.
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021343: Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
Official title: Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arrhythmia
Keywords: Atrial fibrillation
Colchicine
Cardiac surgery
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Detailed description: Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.

Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.

This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.

Eligibility criteria: Inclusion Criteria:

* All consecutive adult patients undergoing elective cardiac surgery

Exclusion Criteria:

* Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
* Known severe liver disease or current transaminases \>1.5 times the upper normal limit
* Current serum creatinine \>2.5 mg/dl
* Known myopathy or elevated baseline preoperative creatine kinase
* Known blood dyscrasias
* Significant gastrointestinal disease
* Pregnant and lactating women
* Known hypersensitivity to colchicine
* Current treatment with colchicine for any indications
* Emergency surgery

Primary outcomes:
measure: The Number of Participants With Atrial Fibrillation
timeFrame: From date of randomization until the date of discharge, assessed up to 2 weeks
measure: The Number of Participants With Colchicine Side Effects
timeFrame: From date of randomization until the date of discharge, assessed up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Khalidi Hospital and Medical Center
name: Ramzi A Tabbalat, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tabbalat RA, Hamad NM, Alhaddad IA, Hammoudeh A, Akasheh BF, Khader Y. Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial. Am Heart J. 2016 Aug;178:102-7. doi: 10.1016/j.ahj.2016.05.006. Epub 2016 May 17.
Clinical trial NCT05220943: The Effect of a Non-Operating Room Anesthesia (NORA) Safety Video on Clinician Anxiety and Perceived Self-Efficacy
Official title: The Effect of a Non-Operating Room Anesthesia (NORA) Safety Video on Clinician Anxiety and Perceived Self-Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Self Efficacy
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the effect of a non-operating room anesthesia (NORA) safety video on clinician anxiety and perceived self-efficacy.

Detailed description: 50 anesthesia professionals will be recruited from the Center for Surgical Innovation (CSI) non-operating room anesthesia (NORA) workforce. Participants will be asked to: Complete a five-minute pre-survey, watch a five-minute video, and then complete a five-minute post-survey.

Eligibility criteria: Inclusion Criteria:

* Individuals employed at Dartmouth-Hitchcock Medical Center (DHMC) in the Department of Anesthesia who are eligible to work in the Center for Surgical Innovation (CSI).

Exclusion Criteria:

* Individuals who are not employed at Dartmouth-Hitchcock Medical Center (DHMC) in the Department of Anesthesia and who are not eligible to work in the Center for Surgical Innovation (CSI).

Primary outcomes:
measure: Change in Anxiety
timeFrame: Before and after watching a five minute video, all occurring on the same day.
Secondary outcomes:
measure: Change in Perceived self-efficacy
timeFrame: Before and after watching a five minute video, all occurring on the same day.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
References:
Clinical trial NCT00804843: Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
Official title: A Randomized Clinical Trial to Evaluate the Effects of High Dose Statin and Niacin Therapy on Excised Plaque Biomarkers in Patients Undergoing Carotid Endarterectomy (CEA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carotid Atherosclerosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers


Eligibility criteria: Inclusion Criteria:

* Patient is diagnosed with carotid stenosis AND is scheduled to undergo carotid endarterectomy
* Female patients of reproductive potential must abstain from sex or use an acceptable method of birth control through out the study

Exclusion Criteria:

* Patient must undergo CEA less than 4 weeks after entering study
* Patient has recent history of acute coronary syndrome
* Patient has has coronary artery bypass graft surgery within 30 days of study start
* Patient has thyroid disease that has not been treated for more than 6 weeks
* Patient has donated blood within 8 weeks of study start
* Patient has poorly controlled diabetes mellitis
* Patient has human immunodeficiency virus (HIV) or Hepatitis B or C
* Patient is taking warfarin or other anticoagulants
* Patient is taking hormone replacement therapy

Primary outcomes:
measure: Composite Score of Plaque Inflammation/Stability Gene Expression as Assayed by Ribonucleic Acid (RNA) Taqman Analysis
timeFrame: At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
measure: Plaque Instability Protein Composite Score
timeFrame: At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
measure: Total Cholesterol and Free Cholesterol Measured by Enzymatic Chromogenic Assay
timeFrame: At time of carotid endarterectomy (after 4 to 12 weeks of dosing)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02613143: Zonulo-hyaloido-vitrectomy for Malignant Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Glaucoma
Keywords: malignant glaucoma
zonulo-hyaloido-vitrectomy
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study was consisted of patients who underwent the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach. The Office of Research Ethics,Eye Hospital of Wenzhou Medical University approved the study protocol, and all patients provided their informed consent.

Brief summary: The purpose of this study is to assess the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach.


Eligibility criteria: Inclusion Criteria:

* patients who underwent the zonulo-hyaloido-vitrectomy for malignant glaucoma through an anterior approach

Exclusion Criteria:

* systemic disease or inflammation

Primary outcomes:
measure: intraocular pressure
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: Yun-e Zhao, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06101043: PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy
Official title: Study on the PECS II Block With Postoperative Pain in Patients Undergoing Single Port Robot-assisted Transaxillary Thyroidectomy: Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. Previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. Analgesic efficacy has been validated during robotic thyroidectomy in our institution. The pain outcomes were comparable between the groups, but there were fewer complications in the PECS II group. The investigators investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy)
* Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination
* Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination
* Patients with a BMI greater than or equal to 18.5 and less than 30.0.

Exclusion Criteria:

* Patients requiring lateral cervical lymph node dissection
* pregnant women
* Uncontrolled diabetes
* Chronic kidney failure
* Patients with previous neck surgery
* Patients with Graves' disease
* People with chronic alcoholism
* Patients with vocal cord paralysis before surgery
* Severe obese patients with a body mass index \>35 kg/m2
* Patients participating in another clinical trial within 30 days
* Patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own
* Patients whose medical staff determines that participation in the study is difficult due to other underlying diseases

Primary outcomes:
measure: Analgesic efficacy
timeFrame: the day after surgery
Secondary outcomes:
measure: Quality of postoperative surgery course
timeFrame: the day after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00678743: An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin
Official title: An Open-label Extension of a Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate Simvastatin 20 mg Plus Omacor 4g Compared to Simvastatin 20 mg Plus Placebo in Subjects With Mixed Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyslipidemias
Keywords: cholesterol
dyslipidemia
omega 3
Lead sponsor: Provident Clinical Research
Sponsor class: OTHER
Collaborators: name: Reliant Pharmaceuticals
First posted: 2008-05-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
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 primary objective of this trial is to assess the continued efficacy of Omacor co-administered with simvastatin for lowering non-high-density lipoprotein cholesterol (non-HCL-C) levels.

Detailed description: The present trial is an open-label, uncontrolled extension to the previous trial (PRV-06009) which utilized a randomized,double-blind, two-period crossover design with eight clinic visits.

The current trial consists of nine clinic visits over 104 weeks. There will be two treatment periods in this study:

* Phase I: All subjects will receive simvastatin 80 md/d plus Omacor 4 g/d for the first six weeks of the trial.
* Phase II: All subjects will receive simvastatin (at a dose to be determined at the discretion of the Investigator) plus Omacor 4 g/d for the remainder of the treatment period.

Eligibility criteria: Inclusion Criteria:

* Must have met all relevant inclusion/exclusion criteria prior to and throughout the previous double-blind study (PRV-06009)
* Must have completed the previous double-blind study to week 12.
* Provide written informed consent and authorization for protected health information

Exclusion Criteria:

* Study drug compliance less than 50% in PRV-06009
* Any ongoing serious adverse event from PRV-06009

Primary outcomes:
measure: Median % Change in Non-HDL-C From Baseline to Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Median % Change in Non-HDL-C From Baseline to Week 52 by Final Dose of Simvastatin
timeFrame: 52 weeks
measure: Median % Change in Non-HDL-C From Baseline to Week 104
timeFrame: 104 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Provident Clinical Research
name: Kevin C. Maki, PhD
role: STUDY_DIRECTOR
References:
citation: Maki KC, Lawless AL, Kelley KM, Dicklin MR, Kaden VN, Schild AL, Rains TM, Marshall JW. Effects of prescription omega-3-acid ethyl esters on fasting lipid profile in subjects with primary hypercholesterolemia. J Cardiovasc Pharmacol. 2011 Apr;57(4):489-94. doi: 10.1097/FJC.0b013e318210fca5.
Clinical trial NCT05389943: The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density After Orally Vitamin D3 Administration
Official title: The Effect of Vitamin D3 Therapy in Post Menopausal Women and Assessment of Changes in Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Vitamin D Deficiency
Keywords: Postmenopausal women, Low Bone density
Lead sponsor: University of Sargodha
Sponsor class: OTHER
Collaborators: name: Government College University Faisalabad
First posted: 2022-05-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized control trial on OPD patients (female age above 50) postmenopausal. the effect of vitamin D supplement on these women's bone density.
Primary purpose: TREATMENT

Brief summary: a study design based on vitamin D deficiency in postmenopausal women with low bone density. pre-test for BMD will be done then vitamin D oral supplements will be provided for the period of 3 months. Post-test of BMD will explore the results.

Detailed description: Sample description Study Design Randomized Control Trial. Settings OPD patients Duration 8 months Sample size 200 Masking Single blind (only Participants) Study subjects Routine visit OPD patients with orthopedic problems Sampling techniques RCT will be done by giving vitamin D (pre-test and post-test of BMD will be done .

Inclusion Criteria Female patients above 50 years (Post-menopausal) Exclusion Criteria All other women Study variables : Independent: Vitamin D Data collection will be done through randomized control trial. Patient with age above 50 years female, with menopausal changes. The BMD test will be done in all participants either placebo or actual treated patients to check the effect of vitamin D3 therapy. Treatment plan includes vitamin D3 at 50,000 International Units daily for 15 days then two times a month for four months along with dietary changes which will consider high dose D3 therapy, and low dose vitamin D3 therapy includes dietary changes along with 1000 international units of Vitamin D3 tablet form. Daily white placebo pills to other group of participants. Bone Mineral Density will be observed through pre-test and Post-test.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal Women

Exclusion Criteria:

* All other women

Primary outcomes:
measure: Postmenopausal women BMD will be improved with oral vitamin D supplements
timeFrame: 3 to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Arsalan Khalid
state: Punjab
Study officials:
References: