louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00541320: Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
Official title: Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: Anti-thrombolytic direct Factor Xa inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.


Eligibility criteria: Inclusion criteria:

* Patients who are scheduled for primary elective unilateral total knee arthroplasty.

Exclusion criteria:

* Women who are not surgically sterile or post-menopausal
* Have a contra-indication to contract venography
* Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.

Primary outcomes:
measure: Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
timeFrame: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
Secondary outcomes:
measure: Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.
timeFrame: Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Clinical Trials Call Center
state: Alabama
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center'
state: Arizona
city: Phoenix
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Yuba City
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: St. Petersburg
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Decatur
country: United States
facility: GSK Clinical Trials Call Center
state: Georgia
city: Charleston
country: United States
facility: GSK Clinical Trials Call Center
state: South Carolina
city: San Antonio
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04641520: Shoulder Profile Among Swimmers and Badminton Players
Official title: A Comparative Study on Shoulder Rotational Strength and Range of Motion Between Unilateral and Bilateral Overhead Elite Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sport Injury
Shoulder Injuries
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elite swimmers and badminton players

Brief summary: Background: To compare the pre-season clinical measures with shoulder rotator strength and range of motion between bilateral (swimmers) and unilateral (badminton players) overhead athletes. Design: Prospective cohort study Participants: 42 athletes were enrolled including 24 elite badminton players and 18 elite swimmers Independent variables: A pre-season visit consisted in clinical and isokinetic shoulder strength testing. Clinical testing consisted in the shoulder range of motion (ROM) measurements aIsokinetic internal and external rotator shoulder muscles strength was tested at 60. Conventional and functional (eccentric-to-concentric) ratios (FR) were calculated.


Eligibility criteria: Inclusion Criteria:

* All the elite badminton players from a high-level club and the National Institute of Sport, Expertise, and Performance
* All the elite swimmers a high-level club

Exclusion Criteria:

* Players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery

Primary outcomes:
measure: Baseline Isokinetic strength testing (peak torques)
timeFrame: one preseason evaluation (september 2017 or september 2018 or september 2019)
measure: Baseline Isokinetic strength testing (ratios)
timeFrame: one preseason evaluation (september 2017 or september 2018 or september 2019)
measure: Clinical measurements, ROM
timeFrame: one preseason evaluation (september 2017 or september 2018 or september 2019)
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References:
Clinical trial NCT00599820: Use of Intravitreal Bevacizumab in Eyes With Choroidal Neovascularization Secondary to Angioid Streaks
Official title: OCT, Visual Outcome and Angiographic Analysis of Choroidal Neovascularization in Six Eyes With Angioid Streaks Treated With a Single Intravitreal Injection of Bevacizumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Angioid Streaks
Choroidal Neovascularization
Keywords: Angioid Streaks
Choroidal Neovascularization
Bevacizumab
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-01-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intravitreal Bevacizumab is an effective treatment for choroidal neovascularization secondary to Angioid Streaks

Detailed description: A consecutive case series of patients with angioid streaks that developed subfoveal choroidal neovascularization were treated with a primary 2.5 mg injection of Bevacizumab (Avastin) intravitreally. All patients were evaluated with BCVA at 1, 2 , 4 and 12 weeks and OCT and fluoresceine angiography at month 1 and 3. (Patients will be follow 6 months)

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Angioid Streaks
* Choroidal neovascularization associated
* Untreated patients or patients treated once with PDT

Exclusion Criteria:

* Ocular surgery excepting uncomplicated phacoemulsification
* Glaucoma or any other ocular pathology

Primary outcomes:
measure: BCVA
measure: Fluoresceine Angiography
measure: Optical Coherence Tomography
Secondary outcomes:
Other outcomes:
Locations:
city: México city
country: Mexico
facility: Asociación para Evitar la Ceguera en México (APEC)
state: Distrito Federal
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Adriana Solís-Vivanco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación para Evitar la Ceguera en México
name: Jans Fromow-Guerra, MD PhD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Mariana Martínez-Castellanos, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Elizabeth Reyna-Castelán, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Myriam Hernández-Rojas, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Griselda Alvarez-Rivera, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Hugo Quiroz-Mercado, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03544320: Prediction Using Connected Technologies for Diabetes
Official title: Prediction Using a Randomized Evaluation of Data Collection Integrated Through Connected Technologies for Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Diabetes
Keywords: Pre-diabetes
diabetes
wearable devices
mobile health
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of two wearable devices and will wear that device for the duration of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, adults with pre-diabetes will be prospectively enrolled for data collection to design prediction models that integrate electronic health record data and patient-generated activity data. Patients will be randomized to receive either a waist-worn or wrist-worn wearable device for 6 months to capture patient-generated activity data.

Detailed description: Patients with suboptimal glycemic control could be better managed if these higher risk patients could be identified and effective interventions were then targeted towards them. However, most practice settings perform infrequent laboratory testing every 3 to 6 months, if not at longer intervals. Current models to predict change in glycemic control perform poorly and do not take into account the behaviors that occur between these intervals. In this study, we will compare different methods to use data on daily health behaviors collected by wearable devices to enhance risk prediction models. Adults with pre-diabetes will complete a series of surveys and baseline assessments and then will be randomly assigned to use a waist-worn or wrist-worn wearable device for 6 months. Measures of HbA1c and LDL will be obtained at baseline and at 6 months.

Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older
2. Be able to provide informed consent
3. Have a smartphone or tablet compatible with the wearable device smartphone application and be willing to use the wearable device for 6 months
4. Baseline hemoglobin A1c of 5.7 to 6.4

Exclusion Criteria:

Participants will no be eligible if they have any medical condition or other reason that will likely prohibit them from completing the 6-month study

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: 6 months
Secondary outcomes:
measure: Change in low-density lipoprotein (LDL) levels
timeFrame: 6 months
Other outcomes:
measure: Hospitalization
timeFrame: 6 months
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Mitesh S Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05656820: Bicuspid Echocardiac Study Team（BEST）
Official title: Prospective Cohort Study on Imaging Genetics of Bicuspid Aortic Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bicuspid Aortic Valve Disease
Lead sponsor: Suzhou Municipal Hospital
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient, inpatient, physical examination or community referral patients.

Brief summary: The Chinese Bicuspid Aortic Valve (BAV) Ultrasound imaging cohort study is a Chinese BAV ultrasound imaging cohort study. At present, a retrospective study cohort involving more than 30 hospitals has been established. The prospective multi-center study of BAV is expected to include and follow up 200 outpatients and inpatients with BAV. The clinical, ultrasound imaging and treatment parameters of the patients are collected and the patients are followed up for 2 years. To analyze the prognostic characteristics of BAV patients and establish a Chinese BAV database. The primary endpoint was all-cause death, and the secondary endpoints were heart failure, angina, severe aortic stenosis, severe aortic insufficiency, ascending aortic diameter ≥50mm, and surgery (surgical and interventional). According to the different pathological types of aortic valve in different types of BAV, ultrasound imaging was used to evaluate the different forms of valvular leaflet lesions and prognosis. Finally, it provides a basis for the prognosis, treatment method, treatment timing and treatment plan selection of BAV patients, and lays a foundation for the mechanism study of BAV arterial lesions and the establishment of risk model for the prognosis of BAV patients.


Eligibility criteria: Inclusion Criteria:

* Ultrasound or other imaging tests to diagnose patients with BAV

Exclusion Criteria:

* Patients with TAV or/and have significant aortic valve calcification
* Those deemed unsuitable for enrollment by clinicians (e.g., end-stage patients, mentally ill patients, non-cooperating patients, etc.)
* Those who do not agree to be included

Primary outcomes:
measure: Diameter of ascending aorta
timeFrame: baseline; once a year; through study completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
Study officials:
References:
Clinical trial NCT04775420: MPV and NLR as Predictors of SBP Diagnosis
Official title: Mean Platelet Volume (MPV) and Neutrophil to Lymphocyte Ratio (NLR) as Predictors of Spontaneous Bacterial Peritonitis in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spontaneous Bacterial Peritonitis
Keywords: Spontaneous bacterial peritonitis
Mean platelet volume
Neutrophil to lymphocyte ratio
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ascites due to decompensated liver cirrhosis admitted at the inpatient section of Tropical Medicine and Gastroenterology Department, Sohag University Hospital.

Brief summary: The aim of the study is to investigate the clinical utility of mean platelet volume (MPV) and neutrophil to lymphocyte ratio (NLR) as diagnostic markers for spontaneous bacterial peritonitis (SBP).


Eligibility criteria: Inclusion Criteria:

* Decompensated liver cirrhosis ascetic patients.

Exclusion Criteria:

* Immunocompromised patients.
* Patients who had received antibiotics before hospital admission.
* Patients on anticoagulant medications, NSAIDs, or oral contraceptive drugs.
* Patients with heart failure, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, hematological disorders, and neoplastic disorders and patients with clinically overt hypothyroidism or hyperthyroidism or with clinically and laboratory-evident autoimmune diseases.

Primary outcomes:
measure: The utility of MPV as non-invasive predictor of SBP
timeFrame: 1 year
measure: The utility of NLR as non-invasive predictor of SBP
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
References:
Clinical trial NCT04388020: Effects of Projected Peripheral Defocus on Ocular Biometrics
Official title: Effects of Projected Peripheral Defocus on Ocular Biometrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery will stimulate physiological changes similar to those in the literature.


Eligibility criteria: Inclusion Criteria:

* Spherical equivalent +2.00 to -4.00 diopters
* Refractive cylinder ≤ 0.75 diopters
* Visual acuity 20/20 -3 or better

Exclusion Criteria:

* Pregnant or lactating
* Active ocular infection
* History of dry eye, strabismus, or amblyopia
* Previous or planned ocular surgery
* Use of medication known to affect vision or accommodation

Primary outcomes:
measure: Axial length (AL)
timeFrame: 1 hour
measure: Choroidal thickness (CT)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Vision Associates/institute of Vision Research
state: New York
Study officials:
affiliation: Manhattan Vision Associates
name: Arkady Selenow, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02365220: Smartphone Application, Mood and Stress
Official title: Smartphone Application, Mood and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smartphone Application
Placebo Effect
Mood
Stress
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
First posted: 2015-02-18
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color.

Detailed description: The overall goal of the outlined study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color. During 14 days, subjects will participate in regular daily training sessions. During another 6 days, subjects will transfer the smartphone-based training to daily life.

Eligibility criteria: Inclusion Criteria:

* Access to smartphone during study period

Exclusion Criteria:

* Severe visual impairment
* Dyschromatopsia
* Severe defective hearing
* Regular intake of medication (excl. contraceptives)
* Severe mental disorders

Primary outcomes:
measure: Change in mood (Assessed via Multidimensional Mood State Questionnaire)
timeFrame: Pre- and post-training, during 20 days of training
measure: Change in perceived stress
timeFrame: Pre- and post-training, during 20 days of training
Secondary outcomes:
measure: Emotional state (Assessed via Self-Assessment-Manikin scales)
timeFrame: Post-training, during 20 days of training
Other outcomes:
measure: Efficacy expectancy (Assessed via Credibility Expectancy Questionnaire)
timeFrame: Post-training, training day 1, 7, 14, 20
measure: Feedback on adverse events during the daily training session (Number of subjects reporting an adverse event)
timeFrame: Post-training, last training day (day 20)
Locations:
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
affiliation: University of Basel, Department of Psychology, Division of Clinical Psychology and Epidemiology
name: Gunther Meinlschmidt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stalujanis E, Neufeld J, Glaus Stalder M, Belardi A, Tegethoff M, Meinlschmidt G. Induction of Efficacy Expectancies in an Ambulatory Smartphone-Based Digital Placebo Mental Health Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 17;9(2):e20329. doi: 10.2196/20329.
Clinical trial NCT02675920: A Study of HCC High Risk Group Using Two Surveillance Tools
Official title: A Prospective Cohort Study to Compare Contrast Enhanced Liver CT and Ultrasonography for Hepatocellular Carcinoma Surveillance in High-risk Group of HCC: Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Keywords: surveillance
ultrasonography
computed tomography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Taejoon Pharmaceutical Co., Ltd.
name: Reyon Pharmaceutical Co., Ltd.
First posted: 2016-02-05
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at high risk of HCC AND High Risk Index (\>=2.33)

Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of anti-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] is positive).

Brief summary: The purpose of this study is to compare sensitivity for hepatocellular carcinoma (HCC) of bi-annual ultrasonography and low dose computed tomography (LDCT) in patients at high risk of HCC.

Detailed description: Patients at high risk of HCC are recommended to undergo biannual surveillance using ultrasound. In this study, LDCT is performed in addition to biannual ultrasound surveillance in eligible patients to compare their sensitivity for HCC. Standard of reference would be follow-up imaging and/or gadoxetic acid-enhanced liver MRI.

Eligibility criteria: Inclusion Criteria:

All conditions have to be satisfied to be enrolled.

* \> 20 years
* high risk group of HCC according to AASLD guideline
* risk index \> = 2.33
* currently on regular biannual surveillance using ultrasonography
* sign informed consent

Exclusion Criteria:

Patients with any of following condition cannot be enrolled.

* previously diagnosed with HCC
* any contraindication of contrast enhanced CT including allergic reaction to iodine
* history of other malignancy

Primary outcomes:
measure: Detection rate of patients with HCC
timeFrame: 18 months
Secondary outcomes:
measure: Detection rate of patients with early HCC
timeFrame: 18 months
measure: False referral rate
timeFrame: 18 months
Other outcomes:
measure: radiation dose per patient
timeFrame: 12 months
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: