louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05472493: Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
Official title: Nuclear Imaging for Subtype Diagnosis of Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Primary Aldosteronism
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-07-25
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: DIAGNOSTIC

Brief summary: This study is to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\[18F\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard.

Detailed description: This is a phase II study (with targeted recruitment of 30 participants) designed to evaluate the accuracy of a novel radiopharmaceutical tracer, para-chloro-2-\[18F\]fluoroethyl etomidate (CETO), used with positron emission tomography (PET) and computed tomography (CT), as a way to subtype unilateral vs. bilateral forms of Primary Aldosteronism, compared to AVS as a reference gold standard. Subjects consenting to study participation will receive the \[18-F\] CETO followed by the PET/CT scan.

Eligibility criteria: Inclusion Criteria:

* Individuals with hypertension
* Individuals with an elevated screening adrenal renin ratio (ARR)
* Individuals with or without spontaneous or diuretic-induced hypokalemia, and/ or plus a discrete adrenal nodule or nodules (1 cm or greater) with concordant lateralization on AVS.

Exclusion Criteria:

* Individuals with chronic kidney disease (estimated glomerular filtration rate \<40 mL/min/1.73m2),
* Individuals with a history of uncontrolled severe hypertension (\>180/110 mmHg), severe uncontrolled diabetes, suspected or proven hypercortisolism (e.g., cortisol-secreting adrenal adenoma), or individuals with an anatomical disease of the liver (e.g., hepatic adenoma or focal nodular hyperplasia)
* Allergy to intravenous contrast, coagulopathy, use of chronic corticosteroids.
* Pregnancy, lactation, and pheochromocytoma.

Primary outcomes:
measure: The primary outcome measure is diagnostic test accuracy (expressed as sensitivity, specificity, positive predictive value, and negative predictive value) for CETO PET/CT using adrenal vein sampling as a reference standard.
timeFrame: It will be measured using adrenal vein sampling approximately the same time as the CETO PET/CT.
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Alexander Leung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792293: Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
Official title: Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Doxorubicin Induced Cardiomyopathy
Keywords: Anthracyclines
Doxorubuicn
Cardiotoxicity
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity

Detailed description: The study participants are female patients with breast cancer receiving Anthracycline based chemotherapy.

They will be divided into 2 groups , the first group will receive 40 mg oral atorvastatin through out the study , while the other group will receive a placebo.

Full echocardiographic study including 3D echocardiography will be done to all patients before starting their chemotherapy and after 6 months.

Eligibility criteria: Inclusion Criteria:

* Female patients diagnosed with histology proven breast cancer with an indication to primary systemic therapy or adjuvant regimens based on anthracyclines

Exclusion Criteria:

* Patients with impaired LV systolic function (EF below 50%)
* Patients with severe valvular heart disease
* Patients previously diagnosed with coronary artery disease
* Patients with baseline elevated liver enzymes
* Patients with prior chemotherapy or radiation therapy
* Pregnant females

Primary outcomes:
measure: Incidence of cancer therapy related cardiac dysfunction among the two groups
timeFrame: Six months
Secondary outcomes:
measure: Changes in left ventricular ejection fraction assessed by 3D echocardiography among the two groups
timeFrame: Six months
measure: Changes in left ventricular volumes assessed by 3D echocardiography among the two groups
timeFrame: Six months
measure: Changes in left ventricular diastolic function among the two groups
timeFrame: Six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
affiliation: Ain Shams University
name: Ahmed L Mohamed, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171093: A 10-12 Week Study to Evaluate the Safety and Efficacy of 320 mg Valsartan and 80 mg Simvastatin in Combination and as Monotherapies in Treating Hypertension and Hypercholesterolemia
Official title: A 10-12 Week Multicenter, Double-blind Study to Evaluate the Efficacy and Safety of the Combination of Valsartan (320 mg) and Simvastatin (80 mg) Compared to Valsartan (320 mg) and Simvastatin (80 mg) Monotherapies in Essential Hypertension and Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HYPERTENSION
HYPERCHOLESTEROLEMIA
Keywords: HYPERTENSION
HYPERCHOLESTEROLEMIA
BLOOD PRESSURE
CHOLESTEROL
VALSARTAN
SIMVASTATIN
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 10-12 week study will provide data on the safety and efficacy of using 320 valsartan and 80 mg simvastatin together compared to using either one alone in lowering blood pressure and LDL cholesterol. After discontinuing current drug therapies for hypertension and hypercholesterolemia, patients will be given 320mg valsartan+80mg simvastatin, 320mg valsartan+placebo, or 80mg simvastatin+placebo..


Eligibility criteria: Inclusion Criteria:

* ESSENTIAL HYPERTENSION
* ELEVATED LDL-C CHOLESTEROL
* USING STABLE DOSE OF HMG CoA REDUCTASE INHIBITOR (STATIN) FOR 3+ MONTHS

Exclusion Criteria:

* SEVERE HYPERTENSION
* EVIDENCE OF HISTORY OR CURRENT HEART DISEASE
* HISTORY OF STROKE OR MYOCARDIAL INFARCTION
* DISLIPIDEMIA OR HYPERTENSION DUE TO SECONDARY CAUSES
* UNCONTROLLED DIABETES OR INSULIN

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change in average ambulatory systolic blood pressure over 24 hours
measure: Change in serum low density lipoprotein cholesterol (LDL-C )
Secondary outcomes:
measure: Adverse events and serious adverse events at each study visit for 42 days
measure: Change in average ambulatory systolic blood pressure over 24 hours between two different treatment therapies
measure: Change in 24 hour ambulatory blood pressure in the daytime compared to nighttime
measure: Change in 24 hour ambulatory blood pressure 21-24 hours after last dose of study medication
measure: Change in total cholesterol, triglycerides, and high densitiy lipoprotein cholesterol (HDL-C) from baseline after 42 days
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT05497193: Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy
Official title: Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focal Epilepsy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 280
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the pediatric outpatient department of our hospital

Brief summary: This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.

Detailed description: This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.

Eligibility criteria: Inclusion Criteria:

(1) Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.

Exclusion Criteria:

(1) syncope (2) Pseudo-seizure(3)transient ischemic attack

Primary outcomes:
measure: clinical efficacy after drug treatment:
timeFrame: one year
measure: EEG changes after drug treatment
timeFrame: one year
measure: safety after drug treatment
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: XI Jing Hospital
state: Shan XI
Study officials:
affiliation: hospital doctor
name: xinwei yang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04592393: Pancreas Cancer Surveillance Using an Abbreviated MRI
Official title: Clinical Feasibility of Abbreviated MRI for Surveillance in High Risk Group for Developing Pancreas Cancer: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Keywords: pancreas cancer
intraductal papillary mucinous neoplasm
magnetic resonance imaging
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2020-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study aims to establish a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI.


Eligibility criteria: Inclusion Criteria:

* On follow-up due to first degree-family history of PAC
* Or on follow-up for BD-IPMN (\>= 2 cm) or main-duct type IPMN (\> 5 mm)
* And signed informed consent

Exclusion Criteria:

* Contra-indication of performing MRI
* Not satisfying the selection criteria.
* Previously diagnosed with pancreatic malignancy
* Pregnancy or planning pregnancy

Primary outcomes:
measure: Detection of pancreas cancer
timeFrame: 1 year after the last surveillance MRI.
Secondary outcomes:
measure: Scan time of abbreviated PB MRI for surveillance
timeFrame: 1 month after the first surveillance MRI.
measure: Estimation of pancreas cancer risk
timeFrame: 1 year after the last surveillance MRI.
measure: Detection of pancreas cancer
timeFrame: 1 year after the last surveillance MRI.
Other outcomes:
measure: Comparison of performance of abbreviated PB MRI
timeFrame: 1 year after the last surveillance MRI.
measure: Identification of super-high risk group of developing pancreas cancer
timeFrame: 1 year after the last surveillance MRI.
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Professor
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02300493: Four Year Weight Change of Cornell Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Keywords: among college students
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2014-11-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Examining the effect of daily self-weighing on the ability of student to prevent from gaining weight during their four years at Cornell.

Detailed description: A group of freshman volunteers were randomly assigned to one of two groups. Both groups were given an internet based scale (Withings). The experimental group was asked to weigh themselves daily. The controls were asked to weigh themselves three times within one week every six months in response to being contacted by our researchers.

Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Body Weight
timeFrame: 3 1/2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Dorms or student houseing
state: New York
Study officials:
References:
Clinical trial NCT00688493: Effects of Single Oral Dose Dapagliflozin QT Study
Official title: A Double-blind, Randomized, Four-period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: QT
Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-06-03
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males


Eligibility criteria: Inclusion Criteria:

* Healthy males age 18 to 45 years of age, who are not currently taking any medications
* Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)

Exclusion Criteria:

* No personal or family history of significant heart problems
* No use of over the counter medications within 7 days of the study
* No use of prescription medicaiton within 1 month of the study

Primary outcomes:
measure: Electronic measures of heart beats
timeFrame: ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication
Secondary outcomes:
measure: Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers
timeFrame: At scheduled times during the 3 day periods following dosing during each of the 4 study periods
measure: Safety and tolerability of dapagliflozin
timeFrame: Screening through completion of the study
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Research Site
state: Maryland
Study officials:
affiliation: AstraZeneca
name: Glenn Carlson, MD
role: STUDY_DIRECTOR
affiliation: Parexel
name: Ronald Goldwater, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02050893: The Effect of Midazolam on Fluid Responsiveness in Septic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Septic Shock
Keywords: septic shock
sepsis
fluid responsiveness
Midazolam
Propofol
haemodynamics
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 40
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: Fluid resuscitation remains the foundation for septic treatment.The evaluation of fluid responsiveness has significance in volume resuscitation for septic shock patients. As the sedative which is commonly used in ICU, Midazolam is supposed to change fluid responsiveness for the pharmacological effect of venodilation. However, the hypothesis has not been certified clinically. In this research, the investigators aim to test the hypothesis that Midazolam can increase fluid responsiveness(using passive leg raising test) in septic shock patients.


Eligibility criteria: Patients are included if they meet the following inclusion criteria:

1. Above 18 years old
2. Endotracheal intubated and mechanical ventilated
3. Awake, can communicate with researchers
4. Diagnosed as septic shock. The definition of septic shock was clarified in Year 2001 ACCP/SCCM guidelines
5. Within 24 hours after the EGDT resuscitation goals are achieved
6. Informed consent are signed.

Exclusion Criteria

1. Under 18 years old
2. Intra-abdominal hypertension
3. Central nerves system dysfunction
4. Heart failure and other cardiac dysfunction such as cardiac conduction block,acute coronary syndrome, cardiogenic shock
5. Proof of volume overload or contradiction of fluid infusion
6. Existence of arterial aneurysm, serious valvular disease,extensive peripheral vascular occlusion disease and insertion of artificial pacemaker

Primary outcomes:
measure: percentage of participants with more than 10% increase of cardiac index by passive leg raising after sedation
timeFrame: Baseline,after sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Critical Care , Zhong-da Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01114893: Travoprost Five Day Posology Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma (OAG)
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-05-03
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: The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.


Eligibility criteria: Inclusion Criteria:

1. either sex and any race/ethnicity, ≥18 years old
2. diagnosed with open-angle glaucoma, and/or ocular hypertension
3. meets the following IOP entry criteria:

   * Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
   * Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
4. satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

1. females of childbearing potential not meeting protocol conditions
2. angle grade less than Grade 2 in either eye
3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
4. severe central visual field loss in either eye
5. any abnormality preventing reliable applanation tonometry in either eye
6. hypersensitivity to prostaglandin analogues or to any component of the study medication

Primary outcomes:
measure: Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5
timeFrame: 5 days
Secondary outcomes:
measure: IOP Change From Baseline at 8 PM on Day 5
timeFrame: 5 Days
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT01168193: Evaluation of Surgical Complications
Official title: Evaluation of Surgical Complications Using a Novel Grading System - A Prospective Single Arm Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Complications
Keywords: surgery
post operative
complications
length of stay
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-07-23
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Surgical complications may be very serious and are often under-reported. The aim of this study it to document and study all the postoperative complications at our department during one year using a novel grading system.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing surgery at our department.
* No gender difference.

Exclusion Criteria:

* Age - less than 18.

Primary outcomes:
measure: Number of complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Haggi Mazeh, MD
role: PRINCIPAL_INVESTIGATOR
References: