louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06307145: Korea Hip Replacement Surgery Registry
Official title: Efficacy and Safety of Hip Replacement Surgery Using Korean National Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Replacement Surgery
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 124556
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 19 or older who received hip replacement surgery

Brief summary: This cohort study obtained data from the Korean National Health Insurance Service (K-NHIS) database. For the hip replacement registry, we included all adult patients older than 19 who received total or hemiarthroplasty surgery between January 1, 2003, and December 31, 2019. Using this registry, we compared efficacy and safety by type of head or liner.

Detailed description: This cohort study obtained data from the Korean National Health Insurance Service (K-NHIS) database. For the hip replacement registry, we included all adult patients older than 19 who received total or hemiarthroplasty surgery between January 1, 2003, and December 31, 2019. Using this registry, we compared efficacy and safety by type of head or liner. The safety issues included the incidence of cancer, orthoperiodic outcome (dislocation, mechanical Cx, periprosthetic join infection, periprosthetic fracture), revision, embolism or thrombosis, cardiac outcome, and death

Eligibility criteria: Inclusion Criteria:

* Patient aged 19 or older who received hip replacement surgery

Exclusion Criteria:

* Insufficient information
* history of any revision

Primary outcomes:
measure: Cancer
timeFrame: the occurrence of cancer, death, or December 31st, 2019 (end of the study), whichever came first.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Juhee Cho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01415245: Vein External Support Trial
Official title: Vein External Support Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Vascular Graft Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.


Eligibility criteria: Primary Inclusion Criteria:

1. Patient scheduled for on-pump CABG on clinical grounds
2. Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds
3. Native circumflex and right coronary arteries have at least one stenosis in each vessel\> 75%

Primary Exclusion Criteria:

1. Concomitant non-CABG cardiac procedure
2. Prior peripheral vascular or cardiac surgery
3. Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Middlesex
country: United Kingdom
facility: Harefield Hospital
city: Oxford
country: United Kingdom
facility: The John Radcliffe Hospital
Study officials:
References:
citation: Taggart DP, Webb CM, Desouza A, Yadav R, Channon KM, De Robertis F, Di Mario C. Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial. J Cardiothorac Surg. 2018 Nov 19;13(1):117. doi: 10.1186/s13019-018-0803-9.
Clinical trial NCT00242645: Computer-Assisted Cancer Risk Behavior Counseling
Official title: Computer-Assisted Cancer Risk Behavior Counseling
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus
Hypertension
Keywords: Doctor-Patient relation
Physician-Patient relation
Diabetes
Office visits
Comparative Study
Health behavior
Randomized controlled trials
Health Promotion
Health Education
Computer-tailor information
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-10-20
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.

Detailed description: Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* Has type 2 (adult-onset) diabetes;
* Developed diabetes after the age of 21;
* Has a scheduled doctor visit about diabetes in the next few months

Primary outcomes:
measure: To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information
Secondary outcomes:
measure: Patient exit interviews after doctor visits about what happened during the visits, such as what was discussed, what tests and consults were ordered and what medications were added or changed.
Other outcomes:
Locations:
Study officials:
affiliation: Thomas Jefferson Unversity
name: Christopher N Sciamanna, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01894945: Dual Time Point PET in Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hodgkin's and Non-Hodgkin's Lymphoma
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed NHL and HL

Brief summary: This study aims to investigate the value of dual time point PET/CT in lymphoma. Since FDG uptake is linked to glucose metabolism, PET imaging is also used to detect suspected sites for infectious and inflammatory disorders. In a clinical setting, it is a challenge to distinguish between FDG uptake in benign and malignant lesions and this gives rise to a considerable quantity of false positive results and decreased positive predictive values. Performing FDG-PET imaging sixty minutes after injection is common practice in the staging and surveillance of lymphoma but this procedure may not be optimal, especially not in settings where benign inflammatory lesions are of clinical concern.

In an attempt to find an alternative method for this discrimination, dual time point FDG-PET was introduced. This technique has shown itself to be a potentially promising method in FDG-PET imaging for distinguishing between malignant and benign lesions using SUV values. The reason for the different FDG uptake patterns between inflammatory and malignant lesions is unclear. Several factors may contribute to this phenomenon on a cellular basis. It has been shown that cancer cells exhibit increased numbers of glucose transporter and low level of glucose-6-phosphatase. Varying levels between different cancer cell types may explain the different FDG uptake curves. Because various cell types exhibit varying rates of FDG uptake we believe that kinetic investigation may prove to be of value in understanding different types of lymphoma and identifying how to perform precise imaging for staging and surveillance.


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Planned for curative treatment

Exclusion Criteria:

* Previously treatment with chemotherapy or irradiation
* Primary CNS lymphoma
* Recurrent lymphoma
* Transformation from indolent lymphoma
* Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
* Pregnancy or lactation

Primary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
measure: Progression free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years, 3 years
Other outcomes:
measure: To compare SUVmax with the expression of GLUT1, hexokinase, G6Pase in lymphoma cells
timeFrame: 1 day (After diagnostic biopsy)
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Department of hematology
city: Roskilde
country: Denmark
facility: Roskilde Hospital
Study officials:
References:
Clinical trial NCT04533945: Feasibility of Using the CGM During TOC From in Persons With T2D Using Insulin
Official title: The Feasibility of Using the FreeStyle Libre Flash Glucose Monitoring System During the Transition of Care (TOC) From Inpatient to Outpatient in Persons With Type 2 Diabetes (T2D) Using Basal/Bolus Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Type 2 Diabetes
Keywords: Continous Glucose Monitoring
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Using the Libre during the TOC with persons with T2D will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. This study aims to assess this with inpatients using insulin.

Detailed description: Integrating the use of the Libre during the TOC will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. Inpatients admitted to the medical-surgical units would be considered based on the inclusion and exclusion criteria. If the patient qualifies they would be consented to participate in the trial. In addition they would be given a script for refills. Primary outcome is change in HbA1c and secondary outcomes at baseline and 90 days include satisfaction, number of ED/inpatient visits, completion of follow-up appointment, and duration of CGM use.

Eligibility criteria: Inclusion Criteria:

* Persons with T2DM
* Persons on atleast 3 injections of insulin/day
* Persons whose insurance will cover the device

Exclusion Criteria:

* Persons with adhesive allergy
* Pregnant women
* Persons with CKD 4/5 or on dialysis

Primary outcomes:
measure: Change in Hemoglobin A1C (HbA1C)
timeFrame: 90 days
Secondary outcomes:
measure: Satisfaction with device assessed by the FreeStyle Libre Telephone Questionnaire
timeFrame: 90 days
measure: Number of ED/inpatient visits
timeFrame: 90 days
measure: Incidence of patients that complete of follow-up appointment
timeFrame: 90 days
measure: Duration of CGM use
timeFrame: 90 days
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Northwell Health North Shore University Hospital
state: New York
Study officials:
References:
Clinical trial NCT03035045: Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis
Official title: Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amniocentesis
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2017-01-27
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. The experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.

Detailed description: Perioperative and postoperative amniocentesis are often painful which cause concerns to those who has to undergo amniocentesis. Anxiety is one of the factor that may prolong operative time, resulting in an increase risk of complication from the procedure. Furthermore, pregnant women, in order to relief the pain, might require others drugs, which has both maternal and fetal side effect. So In conclusion, this study aims to compare efficacy of oral paracetamol premedication and oral placebo premedication by using visual analog scale to evaluate pain.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnant women undergo amniocentesis for the first time at Rajavithi Hospital in 2016-2017

Exclusion Criteria:

* Pregnant women with psychiatric disorder
* Contraindicated to paracetamol
* Pregnant women undergoing amniocentesis due to fetal anomaly
* Take oral paracetamol or other analgesics within 24-48 hrs before operation
* Deny to participate the research

Primary outcomes:
measure: Different in pain score on visual analog scale in amniocentesis between controlled group (placebo) and experimental group (paracetamol).
timeFrame: 1 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT05467345: Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® BGMS in Neonates Using Capillary Blood Samples
Official title: Evaluation of the Performance of CONTOUR NEXT® and CONTOUR PLUS ELITE® Blood Glucose Monitoring Systems (BGMS) in Neonates Using Capillary Blood Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will consist of neonates from hospital wards (e.g. routine/newborn nurseries, SCN, NICU) of the clinical investigational site.

Brief summary: The purpose of this study is to extend the intended use of two BGMSs to include testing of neonatal blood by Health Care Professionals in a clinical setting for the quantitative measurement of glucose levels in neonates.

Detailed description: This trial will evaluate the performance of both the CONTOUR NEXT BGMS and CONTOUR PLUS ELITE BGMS using blood from neonates within a hospital ward, e.g. routine/newborn nurseries, Special Care Nurseries, Neonatal Intensive Care Unit (NICU). The investigational BGMSs will be tested by a Point-of-Care operator using residual heel-stick capillary blood samples from neonates who underwent routine prescribed testing.

Eligibility criteria: Inclusion Criteria:

* Residual capillary (heel-stick) blood samples from neonates (less than 28 days of age) after birth as part of prescribed testing.
* Sample blood volume must be sufficient to complete investigational testing in addition to routine prescribed clinical laboratory testing.

Exclusion Criteria:

* Samples from subjects who are ≥ 28 days of age.
* Samples from subjects who have previously been enrolled into this study.

Primary outcomes:
measure: Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values
timeFrame: 1 day
measure: Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital, Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Dennis Dietzen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03614845: Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery
Official title: Evaluation of Effect of Different Ventilator Mods on Atelectasis in Patients Undergoing Laparoscopic Surgery: a Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Atelectases, Postoperative Pulmonary
Keywords: postoperative atelectasis
mechanical ventilation
laparoscopic surgery
lung ultrasonography
volume controlled ventilation
pressure controlled
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study researchers aim to evaluate effect of different ventilation modalities on the developments of atelectasis by using ultrasound.

Detailed description: Patients undergoing laparoscopic surgery will be randomly assigned either volume controlled ventilation group or pressure controlled volume guaranteed ventilation group. All patients will be performed lung ultrasonography pre and postoperatively to evaluate the development of lung atelectasis and effect of different ventilation modalities on the development of atelectasis.

Eligibility criteria: Inclusion Criteria:

* undergoing laparoscopic surgery
* ASA Status I-II

Exclusion Criteria:

* Gastroesophageal reflux
* obstructive sleep apnea syndrome
* BMI\>30
* severe lung and heart disease
* ASA Status III-IV

Primary outcomes:
measure: Effect of different ventilation mods on development of peroperative atelectasis
timeFrame: at minute 5 in postoperative care unit
Secondary outcomes:
measure: Effect of different ventilation mods on development of peroperative atelectasis
timeFrame: at minute 30 in postoperative care unit
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
city: Kocaeli
country: Turkey
facility: Derince Research and Training Hospital
Study officials:
affiliation: Marmara Unıversity Medical Sciences
name: Ayten Saracoglu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01296945: Nutrition Knowledge for Spanish-speaking Parents
Official title: Nutrition Knowledge for Spanish-speaking Parents: Evaluation of Paper Handouts, Computer Modules and Web Modules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Dental Caries
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Providing child nutrition information is a major goal of every pediatric well-child visit. Unfortunately, due to a wide array of issues, doing this effectively during clinic visits is challenging and insufficient. It is because of this that some have looked for innovative ways to enhance the delivery of this information. One such way is the use of touch screen computer programs containing nutritional information. Several studies have documented the value of patients receiving health information in such a manner.

Nonetheless, the use of this medium has not been well studied in Spanish-speaking care providers of young children. The investigators recently conducted a study that evaluated user's perception of the usability of such technology, finding that most users thought that the touchscreen was easy to use, despite their low computer confidence levels. The investigators also evaluated the impact of using nutrition modules on user's nutrition knowledge, finding that immediately after use; participant's nutrition knowledge was improved. I now propose to evaluate this technology further through a 4 armed randomized controlled trial. The goal here is to evaluate the longer term impact of the educational modules on nutrition knowledge and the impact, if any, of additional web access to the modules, on longer term knowledge. A secondary goal is to better understand nutritional habits in this population and perceptions of weight.


Eligibility criteria: Inclusion Criteria:

* Self identify as Latino/a
* Spanish-speaking
* Over 18 years old
* Primary caregiver to a child 2 years old and under

Exclusion Criteria:

* Child 2 years old and under has significant medical issue requiring special nutrition needs, e.g. g-tube or feeding tube dependent, severe food allergies.
* Person has used the nutrition modules before in prior studies

Primary outcomes:
measure: Knowledge score
timeFrame: Day 14
Secondary outcomes:
measure: knowledge score
timeFrame: Day 1
measure: Knowledge score
timeFrame: 2 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Darcy A Thompaon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: