louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00234858: Tarka vs. Hyzaar in Patients With Metabolic Syndrome (STAR)
Official title: A Phase IV, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Hyzaar® on Glucose Tolerance in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Metabolic Syndrome
Keywords: Hypertension
Metabolic Syndrome
Tarka
Hyzaar
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 280
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether impaired glucose tolerance is improved to a greater degree by Tarka than Hyzaar in subjects with metabolic syndrome


Eligibility criteria: Inclusion Criteria:

* Metabolic syndrome
* Fasting blood glucose between 100 mg/dL and 125 mg/dL
* Hypertension
* One additional criteria, Exclusion 1

Exclusion Criteria:

* Subject has a current diagnosis of Type 1 or Type 2 diabetes mellitus.
* Subject has a hypersensitivity to ACE inhibitor, ARB, CCB, clonidine, methyldopa, hydralazine, or thiazide diuretic medication.

Primary outcomes:
measure: Oral Glucose Tolerance
timeFrame: up to 1 year / 52 weeks
Secondary outcomes:
measure: Changes in blood pressure (BP), pulse rate and BP control. HbA1c, insulin sensitivity, insulin release, albuminuria, lipid profile, AMBP, clinical safety labs and adverse events.
timeFrame: up to 1 year / 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
citation: Bakris G, Molitch M, Hewkin A, Kipnes M, Sarafidis P, Fakouhi K, Bacher P, Sowers J; STAR Investigators. Differences in glucose tolerance between fixed-dose antihypertensive drug combinations in people with metabolic syndrome. Diabetes Care. 2006 Dec;29(12):2592-7. doi: 10.2337/dc06-1373.
Clinical trial NCT02087358: Alcohol Consumption and Stress at Patients Alcohol-dependants
Official title: Alcohol Consumption and Stress at Patients Alcohol-dependants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Dependence
Keywords: alcohol dependence
Stress- correlation
genetic
CRHR1
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes alcohol dependent inpatients participating in a 3 weeks detoxification program.

Brief summary: This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design.

Detailed description: This 3 weeks study examines the correlation between stress and alcohol using an ecological, prospective design. Participants will be given phone calls 4 times a day for 3 weeks, assessing perceived stress and alcohol related craving.

Eligibility criteria: Inclusion criteria:

* Males or Females aged 18-65 years
* Alcohol use disorder defined by DSM 5 criteria
* Fluent in French
* Hospitalized for alcohol withdrawal for at least 7 days
* Viable (working) telephone number

Exclusion criteria:

* Participants without social care insurance
* Any DSM Axis I disorder not defined in the inclusion criteria
* Mandatory psychiatric treatment

Primary outcomes:
measure: Stress level
timeFrame: 3 weeks follow-up
Secondary outcomes:
measure: Genetic association with stress level
timeFrame: 3 weeks follow-up
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier, Service de psychiatrie
Study officials:
affiliation: Psychiatrist Service
name: Yann Le Strat, Pr MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516058: Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model
Official title: Impact Assessment of Simulation-Based Education on Anesthesiology Trainee in Ultrasound-Guided Transversus Abdominis Plane Block Using an Anesthetized Porcine Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesiology Trainee
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study was to investigate the effect of simulation based practice on anesthesiology trainee in ultrasound-guided transversus abdominis plane(TAP) block using an anesthetized porcine model.

The residents filled out a questionnaire before and after the training session. The questionnaires consisted of knowledge including ultrasound anatomy and block technique, comfort, confidence, and axiety levels for the TAP block.


Eligibility criteria: Inclusion Criteria:

* Participants included second-year residents, third-year residents who can participate in the anesthesiology simulation training.

Exclusion Criteria:

* None

Primary outcomes:
measure: impact of a simulation-based ultrasound-guided TAP block training session_Comfort level
timeFrame: within 1 week after training session
measure: impact of a simulation-based ultrasound-guided TAP block training session_Comfort level
timeFrame: within 2 months after training session
measure: impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level
timeFrame: within 1 week after training session
measure: impact of a simulation-based ultrasound-guided TAP block training session_Overall confidence level
timeFrame: within 2 months after training session
measure: impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level
timeFrame: within 1 week after training session
measure: impact of a simulation-based ultrasound-guided TAP block training session_Overall anxiety level
timeFrame: within 2 months after training session
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine , Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05710458: Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
Official title: Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitrectomy
Epiretinal Membrane
Macular Hole
Vitreous Hemorrhage
Retinal Detachment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 72
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: This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.

Detailed description: In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age who are undergoing vitrectomy for the following conditions:

  * Macular hole
  * Epimacular membrane
  * Vitreous hemorrhage
  * Primary retinal detachment

Exclusion Criteria:

* Patient who is

  * unable to give proper consent
  * previous vitrectomy or scleral buckle surgery
  * cases requiring silicone oil tamponed
  * undergoing repeated retinal detachment surgery
  * undergoing surgery for tractional diabetic retinopathy

Primary outcomes:
measure: Duration of Core vitrectomy
timeFrame: intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)
Secondary outcomes:
measure: Non-inferiority of intraoperative and postoperative complication
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
Study officials:
References:
citation: O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4.
citation: Rizzo S, Genovesi-Ebert F, Belting C. Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases. Retina. 2011 Nov;31(10):2007-13. doi: 10.1097/IAE.0b013e318213623a.
Clinical trial NCT02184858: Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
Official title: Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Primary Hypertension
Secondary Hypertension
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.


Eligibility criteria: Inclusion Criteria:

* Parental consent must be granted
* Patient age: 1y - 18 y
* Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
* No reversible cause found on diagnostic work-up for hypertension
* Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension

Exclusion Criteria:

* Pregnancy
* Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
* Following abnormal laboratory values: Hyperkaliemia (serum potassium \> 5.3mmol/L); Anemia (hemoglobin \< 8g/dL); AST or ALT \> 3 times the upper limit of reference range; Total bilirubin \> 3 times the upper limit of reference range
* Abnormalities of the oral cavity that can influence intake of medication
* Known sensitivity to ACE-inhibitors
* Known lactose intolerance
* History of angioedema
* Unilateral or bilateral stenosis of the renal artery
* Diagnosis of heart failure (NYHA Class II-IV)
* History of coarctation of the aorta
* Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication

Primary outcomes:
measure: blood pressure
timeFrame: 4 months
Secondary outcomes:
measure: Serum concentrations will be assessed after every dose titration
timeFrame: trough and 4 hours post dosing
measure: Adverse events with assessment of specific blood parameters
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Pediatrics and Medical Genetics
Study officials:
affiliation: Ghent University, Department of Pediatrics and Medical Genetics
name: Johan Vande Walle, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05680896: SARS-CoV-2 Infection Among Healthcare Workers
Official title: The Risk of SARS-CoV-2 Infection and Severity of COVID-19 Among Healthcare Workers With or Without Previous COVID-19 Vaccines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthcare workers in Nanjing Drum Tower Hospital, Nanjing, China

Brief summary: At present, COVID-19 vaccine is considered as the safest, economic and effective measure to prevent and control COVID-19. Adaptive immunity, including humoral immunity and cellular immunity, plays a role in anti-viral responses. Cellular immunity includes virus specific B cells and T cells, which can provide long-term memory immunity. For acute viral infection, neutralizing antibody is of great significance in preventing infection, while memory cell immunity can maintain a good broad-spectrum and persistence in controlling mutant strains, which is a key factor in controlling viral replication after infection and reducing severe disease and death. However, there is no systematic study on the specific immune response and infection risk of novel coronavirus, and there is no definite conclusion on which specific protective immune response induced by vaccine can reduce the risk of infection. Therefore, this study aims to establish a prospective real-world cohort, analyze the correlation between multiple baseline immune protection indicators and infection risk, follow up the population with breakthrough infection, and monitor the dynamic specific immune response to COVID-19 in peripheral blood and respiratory mucosa. This study will provide an important scientific basis for us to scientifically assess the risk of individual infection with COVID-19.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. SARS-CoV-2 nucleic acid testing showed negative within 72 hours

Exclusion Criteria:

1.Do not consent to enroll in this study

Primary outcomes:
measure: SARS-CoV-2 infection
timeFrame: from Dec 2022 to April 2023
measure: The severity of COVID-19
timeFrame: from Dec 2022 to April 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Chao Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043896: The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Official title: The Effect of Combination Therapy Using Li-ESWT (Low Intensity Extracorporeal Shockwave Therapy) and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2021-09-14
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in erectile dysfunction patients

Detailed description: Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.

Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV

Eligibility criteria: Inclusion Criteria:

* Mild to Moderate Erectile dysfunction
* Married
* Sexually active
* Consenting to participate in the trial

Exclusion Criteria:

* Psychological problems
* Spinal injury
* History of malignancy
* Penile anatomy abnormalities
* Allergic and Contraindications to tadalafil
* On anti-mitotic drugs

Primary outcomes:
measure: Erectile Hardness Score (EHS)
timeFrame: 4 weeks
measure: International Index of Erectile Function (IIEF-5) score
timeFrame: 4 weeks
measure: Peak Systolic Velocity (PSV)
timeFrame: 4 weeks
measure: Vascular Endothelial Growth Factor (VEGF) level in plasma
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: dr. Soetomo General Hospital
state: Jawa Timur
Study officials:
affiliation: Dr. Soetomo General Hospital, Andrology Clinic
name: Tjahjo Tanojo, dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02638558: Evaluation of the Impact of Direct Conversation With Patients in the Compliance With the "Split-dose" Regimen Preparation for Colonoscopy Scheduled in the First Part of the Morning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Preparation Acceptance
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 286
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Split-dose cleansing regimens for colonoscopies, independently from the type of laxative used, are now recommended over full (one day)-dose regimens from all the major guidelines. It is wellknown that splitting the dose (half of the dose the night before and half the day of the colonoscopy) is safe and guarantees a better cleansing of the colon and thus a higher chance of identifying mucosal lesions. This is crucial both in terms of achieving a high-quality colonoscopy and in terms of time and money saved.

Still, there are some issues about compliance and tolerability with split-dose regimens. Two recent prospective works have shown that only a small number of patients (33%) chooses the split-dose regimen when the colonoscopy is scheduled before 10 a.m. and when patients are forced to used the split-dose, 1/7 did not comply with it, especially if the procedure is before 10 a.m. The most common concerns are about early wake-up, travel interruption and fear of incontinence. Both these papers state that strategies to reduce this noncompliance are needed.

The investigators aim to prove whether an "active action" (an oral explanation before the colonoscopy about why split-dose regimens are better) may improve patients' compliance in endoscopies scheduled in the early morning (from 8 to 10 a.m).


Eligibility criteria: Inclusion Criteria:

* every patient who needs a colonoscopy

Exclusion Criteria:

* incapacity in reading and/or in oral comprehension
* contraindications in drinking the preparation

Primary outcomes:
measure: patients compliance in taking split-dose preparation in the early morning colonoscopies
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02846896: The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland
Official title: The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Biliary Cirrhosis
Lead sponsor: Fondazione Epatocentro Ticino
Sponsor class: OTHER
Collaborators: name: Fondazione Epatocentro Ticino
name: Vifor Pharma
name: Intercept Pharmaceuticals
First posted: 2016-07-27
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PBC patients living in Switzerland

Brief summary: PBC is a rare, autoimmune, cholestatic liver disease with genetic and environmental pathogenetic factors. Data about epidemiology of PBC in Switzerland are completely lacking. Epidemiology can be a powerful tool in yielding important clues as to burden and etiology of diseases. In addition, the investigators study will be the first one carried out in the country on PBC, and therefore will raise disease awareness and create a network.


Eligibility criteria: Inclusion Criteria:

* PBC patients living in Switzerland

Exclusion Criteria:

-

Primary outcomes:
measure: Prevalence of PBC in Switzerland
timeFrame: from 1.1.2005 until 31.12.2015
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
Study officials:
References:
citation: Terziroli Beretta-Piccoli B, Stirnimann G, Cerny A, Semela D, Hessler R, Helbling B, Stickel F, Kalid-de Bakker C, Bihl F, Giostra E, Filipowicz Sinnreich M, Oneta C, Baserga A, Invernizzi P, Carbone M, Mertens J. Geoepidemiology of Primary Biliary Cholangitis: Lessons from Switzerland. Clin Rev Allergy Immunol. 2018 Apr;54(2):295-306. doi: 10.1007/s12016-017-8656-x.
Clinical trial NCT00741858: Duragen Versus Duraguard in Chiari Surgery
Official title: Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chiari Malformation
Keywords: Chiari malformation;
Duraplasty;
Posterior fossa decompression;
Duragen;
Duraguard
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 34
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 study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.

Detailed description: The study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. Both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. This study follows patients with Chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.

Eligibility criteria: Inclusion Criteria:

* Symptomatic Chiari malformation

Exclusion Criteria:

* Presence of ventriculoperitoneal shunt
* Pregnancy

Primary outcomes:
measure: Physical Health Quality of Life
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Medical Center in Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Konstantin V Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References: