louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00657839: Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel Group Study to Assess the Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostate Hyperplasia
Vardenafil
Genital Disease
Male: Signs and symptoms of Benign Prostate Hyperplasia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 222
Sex: MALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily administration of 10 mg BID.


Eligibility criteria: Inclusion Criteria:

* Males 45 to 64 years of age
* Lower urinary tract symptoms \> 6 months
* International Prostate Symptom Score \> 12

Exclusion Criteria:

* Prostate Specific Antigen \> 3 ng/ml
* Residual urine volume \> 150 m
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
* Other exclusion criteria apply acc. to Summary of Product Characteristics

Primary outcomes:
measure: International Prostate Symptom Score and maximal urinary flow
timeFrame: 8 weeks
Secondary outcomes:
measure: International Prostate Symptom Score, storing and voiding subscore
timeFrame: 8 weeks
measure: IIEF-EF domains score
timeFrame: 8 weeks
measure: Safety and tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Biberach
country: Germany
state: Baden-Württemberg / 277
city: München
country: Germany
state: Bayern / 280
city: Rosenheim
country: Germany
state: Bayern / 280
city: Starnberg
country: Germany
state: Bayern / 280
city: Weiden
country: Germany
state: Bayern / 280
city: Hamburg
country: Germany
state: Hamburg / 287
city: Hamburg
country: Germany
state: Hamburg / 287
city: Marburg
country: Germany
state: Hessen / 307
city: Tostedt
country: Germany
state: Niedersachsen / 292
city: Osnabrück
country: Germany
state: Niedersachsen / 293
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen / 296
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen / 331
city: Mülheim
country: Germany
state: Nordrhein-Westfalen / 481
city: Leipzig
country: Germany
state: Sachsen / 313
city: Kiel
country: Germany
state: Schleswig-Holstein / 306
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02544139: Specificity Study of Diagnostic for Chagas Disease
Official title: Determination of Estimated Specificity of Chagas Detect Plus Rapid Tests
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Diseases
Lead sponsor: InBios International, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll male and female subjects between 18 and 70 years of age without known risk factors for Chagas. Typically Chagas disease is a chronic, asymptomatic disease.

Brief summary: This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US.

The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole blood samples. Reactive assay results are presumptive evidence of Chagas infection.

This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas infection. A fingerprick blood sample and a venous blood sample (for processing to serum) will be collected from each subject. Subject age, gender, and symptoms will be recorded. For this study, samples will have no personally identifiable information.

CDP and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects 18 to 70 years of age
2. Subjects must be able to answer questions concerning:

   1. Clinical symptoms
   2. Blood transfusions
   3. Organ transplants
   4. Travel or residence in Chagas endemic areas

Exclusion Criteria:

1. Any subject who knows that they have positive serology for Chagas disease
2. Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.

Primary outcomes:
measure: number of subjects with negative result
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
References:
Clinical trial NCT03448939: A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Official title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea
Keywords: papulopustular rosacea
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 361
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: To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.

Detailed description: In this Phase 3, double-blind, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.

Eligibility criteria: Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 18 years of age and older.
3. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 nodules or less.

Exclusion Criteria:

1. Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Primary outcomes:
measure: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
timeFrame: Baseline through Week 12
measure: Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Sol-Gel
state: Florida
Study officials:
References:
Clinical trial NCT03585439: Isthmic Spondylolisthesis Treated With Combined Approach: Clinical and Radiological Outcomes
Official title: Isthmic Spondylolisthesis Treated With Circumferential Arthrodesis Combining Anterior Lumbar Interbody Fusion With Posterolateral Fusion. About 150 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Isthmic Spondylolisthesis
Surgical Procedure, Unspecified
Keywords: Isthmic spondylolisthesis
vertebral fusion
combined approach
circumferential fusion
ALIF
posterior fusion
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive cohort of patients operated in our center from 2013 to 2017

Brief summary: This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis. There is very little literature concerning this procedure.

Detailed description: Isthmic spondylolisthesis can cause back and leg pain. If pain persists after well conducted medical management, a surgical treatment can be proposed. Even though the goal is consensual, there are plenty of ways to reach vertebral fusion: ALIF, PLIF, TLIF, Posterior fusion only, etc... This study aims to evaluate clinical and radiological outcomes of isthmic spondylolisthesis surgically treated with combined approach. The goal is to demonstrate that it is a safe and efficient technique to treat isthmic spondylolisthesis using standard XRays, CT Scan and patient reported outcome measurements. There is very little literature concerning this procedure.

Eligibility criteria: Inclusion Criteria:

* All patients aged over 18 years
* With isthmic spondylolisthesis at L4-L5 or L5-S1
* Operated in our center with a double approach: Anterior lumbar interbody fusion then postero-lateral fusion
* Consent for participation

Exclusion Criteria:

* Pseudarthrosis L5-S1

Primary outcomes:
measure: Fusion status
timeFrame: From 6 months to 1 year after surgery
Secondary outcomes:
measure: Restoration of the foraminal diameter
timeFrame: 3 months and 1 year after surgery
measure: Correction of the spondylolisthesis-induced kyphosis after surgery
timeFrame: 3 months and 1 year after surgery
measure: Segmental lordosis
timeFrame: 3 months and 1 year after surgery
measure: Local Lordosis
timeFrame: 3 months and 1 year after surgery
measure: Back pain
timeFrame: Pre-operative, 3 months and 1 year after surgery
measure: Sciatica
timeFrame: Pre-operative, 3 months and 1 year after surgery
measure: Disability
timeFrame: Pre-operative, 3 months and 1 year after surgery
measure: Complication rate
timeFrame: until 1 year after surgery
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Pare
state: Ile-de-France
Study officials:
References:
Clinical trial NCT00435539: A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)
Official title: A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitreomacular Traction
Keywords: Vitreomacular Traction
Maculopathy
VMT
PVD
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2007-02-15
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: A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.


Eligibility criteria: Inclusion Criteria:

* Patients \>_ 18 years of age with vitreomacular traction

Exclusion Criteria:

* PVD present at baseline
* Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
* Vitreous hemorrhage
* Patients who have had a vitrectomy in the study eye at any time

Primary outcomes:
measure: Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.
timeFrame: Day 14
Secondary outcomes:
measure: Resolution of Vitreomacular Traction (Investigator's Assessment)
timeFrame: Day 28
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA OCMW Antwerpen
city: Ghent
country: Belgium
facility: University Hospital of Ghent
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen K.U.Leuven
city: Munchen
country: Germany
facility: Augenklinik der Universitat Munchen
Study officials:
References:
Clinical trial NCT02843139: Circulating microRNAs for Discriminating Obese Preschoolers at Risk of Diabetes
Official title: Circulating microRNAs as Novel Prognostic Biomarkers in Obese Preschoolers at Risk for Type 2 Diabetes in Adulthood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Discriminate Obese Children at Risk for Diabetes.
Keywords: Circulating microRNA
Childhood obesity
Adulthood diabetes
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 535
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children recruiters were categorized into three groups: obesity, overweight and normal control based on World Health Organization child growth standards. Adults with type 2 diabetes were defined if the individual had a fasting plasma glucose (FPG) level ≥ 7.0 mmol/L.

Brief summary: Childhood obesity certainly increases susceptibility to type 2 diabetes (T2D) in adulthood. Recently, microRNAs (miRNAs) are closely related to various diseases and have been suggested as valuable biomarkers. Here, we sought to identify potential miRNAs to discriminate obese children at risk for diabetes in future.

Detailed description: This study was designed to screen the circulating miRNAs in association with progression from children obesity to type 2 diabetes (T2D) in adulthood. Serum samples were evaluated in a 3 step procedure: 1) discovery study, in which samples from obese children and healthy controls were pooled for miRNA sequecing experiment; 2) cross-sectional validation study, in which miRNAs of interest were validated in all individuals (obese children, overweight children and normal controls); 3) longitudinal validation study, in which the candidate miRNAs were estimated in newly diagnosed diabetes patients and normal glucose tolerance controls (NGT). The final determined miRNAs were further confirmed though primary function studies.

Eligibility criteria: Inclusion Criteria:

Obese preschoolers; Adults with type 2 diabetes; Age-matched healthy controls.

Exclusion Criteria:

-

Primary outcomes:
measure: It is expected that the identification of circulating miRNAs as potential biomarkers may facilitate to the diagnosis of obese preschoolers at high risk for developing diabetes.
timeFrame: 50-70 month old
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01855139: Belgian Real Life Non-interventional Study (NIS) on Xarelto in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism
Official title: Belgian Real Life Non-interventional Study (NIS) on Xarelto® in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism (BOX-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation
Stroke
Systemic embolism
Oral anticoagulation
Real-life setting
Preventive measure
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2013-05-16
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory or hospitalized patients coming from the cardiology clinic of the participating hospitals

Brief summary: The objective of this NIS is to assess in a real-life setting, usage patterns and associated outcomes in the management (healthcare resource utilisation and associated costs) of patients with non-valvular AF treated with Xarelto, in accordance with the terms of the European marketing authorization and the Belgian reimbursement criteria.


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years old with a confirmed diagnosis of non-valvular atrial fibrillation
* Patients must in addition present with at least one of following risk factors:

  * prior stroke, TIA (transient ischemic attack) or non-CNS (central nervous system) systemic embolism
  * left ventricular ejection fraction of \< 40%
  * symptomatic heart failure, New York Heart Association class 2 or higher
  * age ≥75 years
  * age ≥65 years in combination with either diabetes, coronary disease or arterial hypertension

Exclusion Criteria:

* Patients who do not fulfil the Belgian reimbursement criteria

Primary outcomes:
measure: Number of patients with major bleedings
timeFrame: 1 year or 30 days after end of rivaroxaban
measure: Number of patients with symptomatic thromboembolic events
timeFrame: 1 year or 30 days after end of rivaroxaban
measure: All-cause mortality
timeFrame: 1 year or 30 days after end of rivaroxaban
measure: Adverse events
timeFrame: 1 year or 30 days after end of rivaroxaban
measure: Treatment satisfaction measured by means of Anti-clot treatment scale (ACTS)
timeFrame: 1 year or 30 days after end of rivaroxaban
measure: Quantities of resource use consumption
timeFrame: 1 year or 30 days after end of rivaroxaban
Secondary outcomes:
Other outcomes:
Locations:
city: Many locations
country: Belgium
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04598139: Safer Use of Medication in Pediatric Patients at Home
Official title: Safer Use of Medication in Pediatric Patients at Home: Error Reporting Website
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Errors and Other Product Use Errors and Issues
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents or caregivers of children aged from 0 to 14 years.

Brief summary: This study aims:

* to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients.
* to assess de user satisfaction and perceived usefulness of the system.

Participants:

Parents with children who have required drug treatment in the last two months, who have an Internet connection and who agree to participate in the study.

Sample size: 62 participants

Main outcome variable: overall satisfaction


Eligibility criteria: Inclusion Criteria:

* To care children aged under 14 years who have required drug treatment in the last two months
* To have an Internet connection
* To agree to participate in the study.
* To be registered in the study web-based notification system
* Age \> 17 years

Exclusion Criteria:

* To be health provider
* To care children in residence for minors.
* To care children with a life expectancy of less than 2 years.

Primary outcomes:
measure: Satisfaction with the web-based medication error notification system
timeFrame: At one month after use of the website
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Mercedes Gilabert
state: Alicante
Study officials:
References:
Clinical trial NCT05127239: The Effectiveness of Smartphone Application on the Serevity of Obstructive Sleep Apnea
Official title: Constructing a Care Model Combing Smartphone Application to Improve Obstructive Apnea in Obesity Adults: a Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
home portable sleep monitor
smartphone application
lifestyle modification intervention
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 146
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: A two-year study design is formulated. The overall aim of this study is to examine the effectiveness of the care model combing smartphone application on improve obstructive apnea in obesity adults.

Detailed description: This study was the second year.The purpose of this study is to evaluate the effectiveness of the lifestyle modification intervention for overweight employees with obstructive sleep apnea. A randomized control trial with single blind will be used. Stratified with proportional randomized sampling will be employed and 160 suitable participants will be recruited from 4 electronics industries in northern of Taiwan. The subjects will be randomly divided into three groups. The total duration of intervention program is 6 months. Only the intervention group received the Combining Smartphone Application with lifestyle modification Intervention. The home portable sleep monitor will be used to collect the change of AHI at baseline, 3, and 6 months after intervention.

Eligibility criteria: Inclusion Criteria: a) \>21 years old; b) )BMI greater than24 kg/m2; (c) the absence of any mental disorder, alcohol and drug addiction, and serious disease, such as cancer or cardiorespiratory failure; and d) Screening for OSA , AHI\>5 and voluntary participation.

-

Exclusion Criteria:

* a) diagnosis of OSA and currently under treatment and；b) diagnosis of severe depression (c) have cardiopulmonary diseases and are not suitable for activities; and d) plan to become pregnant during or within 6 months

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: one night
Secondary outcomes:
Other outcomes:
Locations:
city: Miaoli
country: Taiwan
facility: Phison Electronics Corp
Study officials:
affiliation: Department of Graduate Institute of Health Care, Chang Gung University of Science and Technology
name: Hsiu-Chin Hsu, e-mail
role: PRINCIPAL_INVESTIGATOR
References: