louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03963609: Multi-slice CT Coronary Angiography in Patients With Stable Angina
Official title: Multi-slice CT Coronary Angiography Assessment of Remodeling Index in Patients With Low to Intermediate Risk Stable Angina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Stable Angina
Keywords: chronic stable angina
multislice CT
remodeling index
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: evaluation of coronary artery remodeling index in patients with low to intermediate risk stable angina by MSCT coronary angiography.

Brief summary: early identification of vulnerable plaques by remodeling index prior to rupture and development of acute event is of considerable importance especially by a reliable non-invasive method as CT coronary angiography.

Detailed description: single-center, cross section, observational study included 150 patients with stable angina with normal resting ECG, negative markers, normal systolic function by 2D echocardiography (EF\>50%) and without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.

Eligibility criteria: Inclusion Criteria:

* first attack, low to intermediate risk stable angina
* normal resting ECG,
* negative markers
* normal systolic function by 2D echocardiography (EF\>50%)
* without regional wall motion abnormality at rest who were referred to MSCT evaluation of the coronary artery tree.

Exclusion Criteria:

* previous acute coronary syndrome or revascularization, those with renal impairment or dye hypersensitivity, patients with morbid obesity (BMI\>40kg/m²), rhythm other than sinus rhythm inability to hold breath for 10sec to acquire the image lesions with heavy calcium score.

Primary outcomes:
measure: remodeling of the coronary artery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mostafa SA, Aboelazem T, Sanad O, Abdelghafar H, Azam A. Multi-slice CT coronary angiography assessment of remodeling index in patients with low- to intermediate-risk stable angina. Egypt Heart J. 2019 Sep 11;71(1):7. doi: 10.1186/s43044-019-0011-5.
Clinical trial NCT00654407: Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia
Official title: An Open Label, Randomized, Multi-Center, Phase IIIB, Parallel Group Switching Study to Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Cholesterol
hypercholesterolemia
Coronary Heart disease
low density lipoproteins
Rosuvastatin
Atorvastatin
simvastatin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 4875
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 determine whether treatment with rosuvastatin following atorvastatin or simvastatin treatment will improve health outcomes for patients at high risk of Coronary heart disease compared to atorvastatin and simvastatin alone.


Eligibility criteria: Inclusion Criteria:

* Discontinuation of all cholesterol lowing drugs, including dietary supplements.
* Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.
* Abnormal laboratory parameters as defined in the protocol.

Primary outcomes:
measure: Low density Lipoprotein cholesterol level - reaching internationally recognised LDL cholesterol goal levels.
timeFrame: 16 weeks
Secondary outcomes:
measure: Percentage change in other cholesterol & triglyceride measures
timeFrame: 16 weeks
measure: Safety evaluation
timeFrame: 8 & 16 weeks
measure: To compare the efficacy of rosuvastatin with atorvastatin and simvastatin
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Joel Raichlen
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
citation: Ballantyne CM, Raichlen JS, Cain VA. Statin therapy alters the relationship between apolipoprotein B and low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol targets in high-risk patients: the MERCURY II (Measuring Effective Reductions in Cholesterol Using Rosuvastatin) trial. J Am Coll Cardiol. 2008 Aug 19;52(8):626-32. doi: 10.1016/j.jacc.2008.04.052.
Clinical trial NCT06195007: Motivational Interviewing for Stroke
Official title: Motivational Interviewing to Improve Outcomes After Stroke or Transient Ischemic Attack Attributable to Tobacco Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Transient Ischemic Attack
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Accreditation Council for Graduate Medical Education
First posted: 2024-01-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Motivational interviewing (MI) is a style of communication designed to elicit a person's own reasons for change to drive commitment toward a goal. The goal of this study is to assess the effect of trainee-led MI on patients diagnosed with acute stroke or TIA attributable to modifiable risk factors in comparison to conventional post-stroke counseling, based on patient outcomes, and meaning of work and sense of fulfillment for trainees.


Eligibility criteria: Inclusion Criteria:

* Patient presentation consistent with a stroke or TIA
* Patient is a current tobacco user and tobacco use contributed to the stroke
* Resident enrolled in study assigned to Vascular Neurology service during patient admission.

Exclusion Criteria:

* Patient unable or unwilling to follow up in the outpatient stroke clinic after discharge
* Patient has cognitive impairment or aphasia that would preclude meaningful participation in motivational interview (defined as a score of 0 on the National Institute of Health Stroke Scale \[NIHSS\] questions 1 and 9)

Primary outcomes:
measure: Smoking cessation at 90-day post-discharge follow up
timeFrame: 90 days post-discharge
measure: Patient rating of ability to improve their health
timeFrame: 90 days post-discharge
measure: Recurrence of stroke / TIA symptoms
timeFrame: 90 days post-discharge
Secondary outcomes:
measure: Patient ability to take stroke prevention medications as prescribed
timeFrame: 90 days post-discharge
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Christina Wilson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01838707: Postoperative Epidural Analgesia in Spine Fusion Surgery
Official title: Postoperative Epidural Analgesia in Spine Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: postoperative
spine surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we aim to compare the analgesic effect of 0.125% bupivacaine HCL, 0.125% bupivacaine HCL + Morphine sulphate 3 mg, 0.125% bupivacaine HCL + Fentanyl 100 micro gram both at rest and mobilization maneuvers.


Eligibility criteria: Inclusion Criteria:

* patients undergoing spine fusion surgery.

Exclusion Criteria:

* Drug addiction. Intraoperative dural tear. Uses of opioids drug for any reason in the previous 48 hours. Mental dysfunction. Spinal fusion for any infectious or malignant causes.

Primary outcomes:
measure: Assessment of pain
timeFrame: first 3 postoperative days
Secondary outcomes:
measure: assessment of patients' satisfaction
timeFrame: First 3 postoperative days
Other outcomes:
measure: beta-endorphin
timeFrame: 1st postoperative day
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Omnia A Abd El Raof, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01777607: The Use of Impella RP Support System in Patients With Right Heart Failure
Official title: The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Right Heart Failure
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.


Eligibility criteria: Inclusion Criteria:

1. Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
2. Age ≥18 years old
3. Signed Informed consent

Exclusion Criteria

1. INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
2. Evidence of acute neurologic injury
3. RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
4. Intolerance to anticoagulant or antiplatelet therapies
5. Existing congenital heart disease that would preclude the insertion of the device.
6. Participation in any other clinical investigation that is likely to confound study results or affect study outcome
7. Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)

Primary outcomes:
measure: Primary Benefit Endpoint
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Henry Ford Hospital
name: William O.Neill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein Medical Center
name: Mark Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson MB, Goldstein J, Milano C, Morris LD, Kormos RL, Bhama J, Kapur NK, Bansal A, Garcia J, Baker JN, Silvestry S, Holman WL, Douglas PS, O'Neill W. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015 Dec;34(12):1549-60. doi: 10.1016/j.healun.2015.08.018. Epub 2015 Sep 8.
Clinical trial NCT00374907: A Study Assessing Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Official title: Mechanism of Action and Efficacy of Saxagliptin (BMS-477118) in the Treatment of Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-09-12
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn whether Saxagliptin can improve the body's ability to make its own insulin and lower blood sugar in people with type 2 diabetes

Detailed description: All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to receive open-label metformin added onto their blinded study medication

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Drug naive
* Hemoglobin A1c (HbA1c) ≥6.0% and ≤8.0%
* Fasting C-peptide ≥1.0 ng/mL
* Body mass index ≤40 kg/m²

Exclusion Criteria:

* Recent cardiac or cerebrovascular event
* Elevated serum creatinine

Primary outcomes:
measure: Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
measure: Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period
timeFrame: 116 weeks
measure: Marked Laboratory Abnormalities - During ST + LT Treatment Period
timeFrame: 116 weeks
Locations:
city: San Diego
country: United States
facility: Va San Diego Healthcare System
state: California
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc,, Inc.
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04016207: Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin
Official title: Non-interventional Trial to Investigate the Change of Psychopathological Markers of Affective Dysregulation (AD) in Children With Attention Deficit Hyperactivity Disorder (ADHD) Treated by Guanfacin, a Pilot Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Affective Dysregulation
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Veit Roessner and PD Dr. Robert Waltereit jointly lead and conduct the study
First posted: 2019-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of ADHD, Age 6-17 years

Brief summary: Early onset, high prevalence and persistence, as well as developmental comorbidity make affective dysregulation (AD) in childhood one of the most psychosocially impairing and cost-intensive mental conditions. Despite continuous research, there is still a substantial need for optimization of individual treatment strategies in order to improve outcomes and to reduce subjective and economic burden. Here we want to study the change of psychopathological markers of affective dysregulation (AD) treatment of affective dysregulation (AD) in children with Attention Deficit Hyperactivity Disorder (ADHD) treated by Guanfacine. These children did not respond to methylphenidate treatment. The results will allow the generation of a hypothesis for a randomized clinical trial to investigate the efficacy and safety of Guanfacine for the treatment of AD in children.


Eligibility criteria: Inclusion Criteria:

* male and female patients (aged 6 to 17 years)
* clinical diagnosis of ADHD (F90.0) or comorbid ADHD and Oppositional defiant disorder (ODD) (F90.1)
* patients with ADHD who did not respond to stimulants
* DADYS is an instrument to assess AD and has a domain for disruptive behaviors. Inclusion criterion for the study is a score of at least moderate (middle) severity in the DADYS parents version this domain
* IQ must be at least 70
* Patients receiving or intended to receive Guanfacin
* Written informed consent by the custodian and the children

Exclusion Criteria:

* unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
* current substance abuse

Primary outcomes:
measure: DADYS-EF (Diagnostikum für Affektive Dysregulation, Eltern-Fragebogen)
timeFrame: 9 weeks
Secondary outcomes:
measure: DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen)
timeFrame: 9 weeks
measure: Conners3L
timeFrame: 9 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Technical University Dresden, Child and Adolescent Psychiatry
name: Veit Roessner, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05070507: Effect of an Enzyme-containing Lozenge on Dental Biofilm in Healthy Individuals.
Official title: Preventive Effect of an Enzyme-containing Lozenge on Dental Biofilm Accumulation in Healthy Individuals: A Clinical Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Gingivitis
Microbial Colonization
Lead sponsor: Novozymes A/S
Sponsor class: INDUSTRY
Collaborators: name: University of Aarhus
First posted: 2021-10-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to assess the effect of an enzyme containing lozenge on dental plaque accumulation in healthy adults.

Detailed description: The purpose of this study is to examine the clinical effects of a lozenge containing enzymes on dental plaque accumulation and oral microbiome composition after professional dental cleaning, as compared to a placebo lozenge without enzymes. Furthermore, safety of the enzyme lozenge will be assessed by clinical evaluation of the oral hard and soft tissues. The null hypothesis is that the treatment with enzyme-containing lozenges do not affect plaque accumulation, as compared to a placebo control.

Eligibility criteria: Inclusion Criteria:

* Generally healthy males and females ≥18 years of age.
* Able to read, sign and receive a copy of the signed informed consent form.
* Have at least 20 natural teeth.

Exclusion Criteria:

* Clinically visible active caries lesions and/or periodontitis.
* Significant oral soft tissue pathology based on a visual examination.
* History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
* History of allergies to ingredients in the test product.
* History of allergies towards enzymes.
* Self-reported as pregnant or nursing.
* Self-reported serious medical conditions.
* Antibiotic or anti-inflammatory medication within 30 days of screening visit.
* Orthodontic appliances, including retainers, peri/oral piercings, or removable partial dentures.
* Acute sinusitis or severe oral-pharyngeal infections.

Primary outcomes:
measure: Accumulation of dental plaque after 24 hours
timeFrame: Change in dental plaque score from baseline to 24 hours' follow-up
Secondary outcomes:
measure: Accumulation of dental plaque after 7 days
timeFrame: Change in dental plaque score from baseline to 7 days' follow-up
measure: Development of gingivitis after 7 days
timeFrame: Change in gingivitis score from baseline to 7 days' follow-up
measure: Microbial characterization of the oral microbiome from plaque and saliva samples
timeFrame: 7 days' follow-up
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Sebastian Schlafer, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00486707: Ovarian Cancer Patient Questionnaire on Genetic Testing
Official title: Questionnaire for Ovarian Cancer Patients Regarding Acceptance and Willingness to Undergo Genetic Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Questionnaire
Genetic Testing
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 237
Sex: FEMALE
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: Study participants with a diagnosis of ovarian cancer.

Brief summary: The objective of this study is to evaluate the willingness of patients with ovarian cancer to undergo genetic testing, given the cost, their understanding and acceptance of genetic testing and the possibility of targeted therapy.

Detailed description: All eligible patients being seen in the Gynecology Center at the M.D. Anderson Cancer Center and at Gynecologic Oncology of Houston for follow-up or a new diagnosis of ovarian cancer will be asked to participate in this study by completing a questionnaire.

This study will end when 400 completed questionnaires have been collected. We estimate that 40-60 ovarian cancer patients are seen in the Gynecology Center at the M.D. Anderson Cancer Center each week and that 20- 40 ovarian cancer patients are seen at Gynecologic Oncology of Houston each week. The completion of 400 questionnaires will provide adequate data to address our question in an expeditious time frame. The initial phase of this study is exploratory and does not involve a comparison group.

Eligibility criteria: Inclusion Criteria:

* Patients must have the diagnosis of ovarian cancer.
* Patients must be at least 18 years of age at the time of enrollment.
* Patients must be able to read and write in the English language.

Exclusion Criteria:

* Patients that are unable to speak or write in the English language. Currently, the investigators' resources in genetic counseling are limited. In the future, they plan to expand the questionnaire and study to include additional languages.
* Patients having previously undergone BRCA genetic testing.

Primary outcomes:
measure: Participants' Response to Survey Questions (Yes/No)
timeFrame: 15-20 minutes to complete survey
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen H. Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lacour RA, Daniels MS, Westin SN, Meyer LA, Burke CC, Burns KA, Kurian S, Webb NF, Pustilnik TB, Lu KH. What women with ovarian cancer think and know about genetic testing. Gynecol Oncol. 2008 Oct;111(1):132-6. doi: 10.1016/j.ygyno.2008.06.016. Epub 2008 Aug 6.