louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03675828: Virtual Visits in Heart Failure Care Transitions
Official title: Virtual Visits in Heart Failure Care Transitions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Distance Health
Virtual Health
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 116
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the use of virtual visits in the post-discharge care of patients with heart failure. Participants admitted to the hospital with a primary diagnosis of heart failure will be randomized at discharge to either a virtual visit or outpatient visit for their 7-day post discharge follow up visit.

Detailed description: Published guidelines recommend that patients being discharged home after hospitalization for HF should be offered a 7-day post-discharge outpatient clinic visit as a way to increase engagement with care and reduce risk of poor outcomes. Unfortunately no-show rates for the 7-day post-discharge outpatient visit in this population are high, suggesting poor engagement. The investigators have previously observed a 76% no-show rate at the Cleveland Clinic Main Campus. This study is to evaluate whether use of 7-day post-discharge virtual visit versus in-person visit can improve adherence with post-discharge appointment.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized for primary diagnosis of HF;
2. Anticipated to be discharged home;
3. Agreeable to longitudinal post-discharge care at Cleveland Clinic Main Campus in the first few weeks after hospital discharge;
4. Patient or an individual in their social support network has the ability (equipment and connectivity) to do a virtual visit after hospital discharge;

Exclusion Criteria:

1. Being transferred to another hospital, or being discharged to an inpatient facility or nursing home;
2. Being discharged to hospice;
3. Subject currently enrolled in an interventional research study that requires an in-person clinical visit within 7 days post-discharge.

Primary outcomes:
measure: Proportion of completed post discharge visits via virtual visit or in outpatient setting
timeFrame: 12 months
Secondary outcomes:
measure: 45-day unplanned readmission and death measures stratified by visit method (virtually or in-person)
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Wai Hong Wilson Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorodeski EZ, Moennich LA, Riaz H, Jehi L, Young JB, Tang WHW. Virtual Versus In-Person Visits and Appointment No-Show Rates in Heart Failure Care Transitions. Circ Heart Fail. 2020 Aug;13(8):e007119. doi: 10.1161/CIRCHEARTFAILURE.120.007119. Epub 2020 Jul 30. No abstract available.
Clinical trial NCT06257628: MACE CDS Software Master Enrollment Protocol
Official title: MACE CDS Software Master Enrollment Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Events
Keywords: Emergency Department
Major Adverse Cardiac Events
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 5515
Sex: ALL
Minimum age (years): 23
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting ED with suspicion of Acute Coronary Syndrome (ACS).

Brief summary: This protocol will collect real world EHR data to support the product development life cycle activities associated with developing the Major Adverse Cardiac Events (MACE) Clinical Decision Support (CDS) software.

The data will also be utilized in subsequent clinical validation to support an FDA application and/or applications to other regulatory agencies as needed.

Detailed description: The primary objective is to develop a machine learning tool which predicts risk of 30-day MACE (major adverse cardiac event) risk stratification among patients visiting ED with suspicion of ACS (Acute Coronary Syndrome).

The data will also be utilized in subsequent clinical validation. In addition to retrospective Electronic Health Record (EHR) data, Health Information Exchange (HIE) data and patient reported outcomes will be collected to capture 30-day MACE outcomes, as applicable.

Eligibility criteria: Inclusion Criteria:

* All genders, races, ethnicities

Exclusion Criteria:

* ≤ 18 years old presenting to the ED and for clinical validation only, adults \< 22 years old

Primary outcomes:
measure: Performance Characteristics NPV (Negative Predictive Value), Specificity and Sensitivity
timeFrame: Within 30-days from the Emergency Department Visit with suspicion of ACS (Acute Coronary Syndrome)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Kettering
country: United States
facility: Kettering Health
state: Ohio
Study officials:
affiliation: Beckman Coulter
name: Alicia Drain
role: STUDY_DIRECTOR
References:
Clinical trial NCT04585828: Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy
Official title: Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy for Treatment of Neonatal Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized study of phototherapy for neonatal hyperbilirubinemia. The intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. Both treatments are well known and used. The primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.


Eligibility criteria: Inclusion Criteria:

* Neonatal icterus and total serum bilirubin above threshold for phototherapy.
* Gestational age ≥ 33 weeks
* Birth weight ≥ 1800 gr
* Postnatal age \> 24 hours and \< 2 weeks

Exclusion Criteria:

* Hemolysis due to isoimmunization
* Very high or rapidly rising total serum bilirubin

Primary outcomes:
measure: Questionnaire on the parents experience with the phototherapy treatment
timeFrame: Day 1 of phototherapy
Secondary outcomes:
measure: Effect of phototherapy
timeFrame: Measurement of bilirubin before phototherapy and after 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04000828: Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
Official title: Comparison of Sensimed Triggerfish (TF) 24 Hour Monitoring of the Eye in Glaucoma Patients Before and After Trabeculectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy


Eligibility criteria: Inclusion Criteria:

* Patient must have the willingness and ability to provide signed informed consent
* Patient is able to comply with the study procedure
* Patient must be ≥ 18 years old
* Diagnosis of primary open angle glaucoma (EGS criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye
* planned trabeculectomy in the study eye
* in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Visual Acuity of 20/200 or better in both eyes
* Ability of subject to understand the character and individual consequences of the study

Exclusion Criteria:

* Subjects with contraindications for wearing contact lenses in the study eye
* secondary glaucoma in the study eye
* History of refractive surgery in the study eye
* History of intraocular surgery in the last three months in the study eye
* Severe dry eye syndrome as judged by the investigator in the study eye
* Keratoconus or other corneal abnormalities
* Any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision
* Conjunctival or intraocular inflammation in the study eye
* Simultaneous participation in other clinical trials
* Previous IOP-lowering intervention in the study eye
* Current shift workers (applicable for at least 3 months)
* Transmeridian flight \< 2 months before screening (6 hours time shift)
* Subjects with pacemaker

Primary outcomes:
measure: Amplitude
timeFrame: up to 14 weeks
Secondary outcomes:
measure: Correlation of other parameters
timeFrame: up to 14 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Clinical Trial Site, Department of Ophthalmology, University Medical Center Johannes Gutenberg University Mainz
Study officials:
References:
Clinical trial NCT01893528: Study to Assess the Safety and Tolerability of Ascending Single Doses of REGN2009 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1, randomized, double-blind, placebo-controlled first-in-human (FIH) study to assess the safety and tolerability of ascending single doses of REGN2009 administered to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women ages 18 to 65 years inclusive
2. Body mass index between 18.0 kg/m\^2 and 30.0 kg/m\^2, inclusive

Exclusion Criteria:

1. Pregnant or breast-feeding women
2. Any clinically significant abnormalities observed during screening (day -21 to day -2)
3. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen, and/or positive hepatitis C antibody at the screening visit
4. History of drug or alcohol abuse within a year prior to the screening visit (day -21 to day -2)
5. Hospitalization for any reason within 60 days of the screening visit (day -21 to day -2)
6. Participation in any clinical research study within 30 days of the screening visit (day -21 to day -2) or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
7. History of a hypersensitivity reaction to doxycycline or similar compound
8. Any medical or psychiatric condition which, in the opinion of the investigator, would place the subject at risk, interfere with participation in the study or interfere with the interpretation of the study results
9. Previous adverse experience to any biological investigational or therapeutic agent
10. Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Primary outcomes:
measure: Number of TEAEs
timeFrame: day 1 to day 106/ visit 15
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT02223728: Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury
Official title: Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2014-08-22
Enrollment: 79
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventions to help individuals with traumatic brain injury manage their healthy lifestyle behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a telehealth lifestyle program on reductions in weight and improvements in health behaviors/lifestyle choices.


Eligibility criteria: Inclusion Criteria:

1. age 19 years or older
2. English speaking
3. sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
4. overweight or obese as defined by a BMI score of ≥ 25 kg/m2
5. 1-year or greater post-injury
6. not currently enrolled in a weight loss program or receiving weight loss medication
7. regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously
8. if person with TBI who meets criteria 1-7 but does not cook, shop, and/or prepare meals independently, he or she must have a non-paid, study partner willing to participate in the study.

Exclusion Criteria:1

1. pregnant or planning to become pregnant in the next 7 months
2. concurrent medical condition for which changes in exercise or diet would be contraindicated
3. severe hearing or visual impairment
4. significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
5. unable to communicate
6. significant cognitive impairment and without a study partner, and/or
7. person with TBI who does not cook, shop, and/or prepare meals independently who does not have a non-paid, study partner willing to participate in the study
8. currently enrolled in an organized weight loss program
9. has lost \> 10% of body weight over the past 6 months
10. history of an eating disorder

Primary outcomes:
measure: Body Mass Index (BMI) scores
timeFrame: Changes in baseline and post-program BMI scores at 7-months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham/Spain Rehabilitation Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Dreer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06252428: Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals
Official title: Detection of Biofilm Among Uropathogenic Escherichia Coli Clinical Isolates in Suez Canal University Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Escherichia Coli Infections
Keywords: Uropathogenic E. coli
biofilm
antibiotic resistance
MTCP
CRA
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients of both sexes and all age groups attending different departments in Suez Canal University hospitals.

Brief summary: This descriptive cross-sectional study will beconducted in Suez Canal University Hospitals (SCUHs) in Ismailia, Egypt. The study aims to detect Escherichia coli biofilm producers to improve prognosis and treatment and reduce morbidity and mortality rates due to this infection.

Detailed description: Forty seven clinical isolates of non-duplicated UPEC will be collected from clinically suspected cases of UTI in different departments in SCUHs. Isolates will be identified as E. coli by colony morphology, Gram staining and biochemical reactions. Antimicrobial sensitivity testing will be performed by Kirby-Bauer disc diffusion method on Muller-Hinton agar plate. The detection of biofilm will be carried out by Congo Red Agar (CRA) method and modified tissue culture plate (MTCP) method.

Eligibility criteria: Inclusion Criteria:

* Patients showing criteria for Symptomatic Urinary Tract Infection (SUTI) according to Center of Diseases and Control criteria (CDC) (CDC, 2022).

Patient has at least one of the following signs or symptoms:

* fever (\>38.0°C)
* suprapubic tenderness
* costovertebral angle pain or tenderness
* urinary urgency
* urinary frequency
* dysuria

Exclusion Criteria:

* 1. Patients received antibiotic treatment in the last 48 hours 2. Refusal of the patients to participate in the study

Primary outcomes:
measure: antibiotic resistance
timeFrame: from 18-24 hours
measure: Congo red Agar method (CRA)
timeFrame: 24 to 48 hours
measure: Modified tissue culture plate method (MTCP)
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of Medicine, Suez canal university
Study officials:
affiliation: Faculty of Medicine - Suez Canal University
name: Rania Kishk, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04453228: Analysis of the Mass Skiers' Injury in a Large Ski Resort in Chongli, China
Official title: Analysis of the Mass Skiers' Injury in a Large Ski Resort in Chongli, China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skiing Injury
Keywords: Ski resorts
Skiing
Sports injury
The winter Olympics
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 753
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During the 2017-2018 and 2018-2019 snow season, the injured skiers were amateurs.There were teenagers and teachers.But most of them were young and middle-aged.

Brief summary: This study takes the injury situation of a large ski resort in Chongli during the 2017-2018 and 2018-2019 snow seasons as an example, aiming to preliminarily understand the injury situation of mass skiing in ski resorts in China, and provide a basis for predicting the rapidly growing medical demand for treatment and treatment of ski injuries in the context of 2022 Winter Olympic Games.

Detailed description: Objective: To make a retrospective analysis of the injuries of skiing population in a large ski resort in Chongli, China and provide a basis for predicting the rapidly increasing medical needs for ski injuries in the context of the 2022 winter Olympic Games.

Methods: The basic data of all injured skiers who were treated in a medical station of a large ski resort in Chongli during the 2017-2018 and 2018-2019 snow seasons were collected. The number of skiers, the number of injuries, the causes of injuries, the types of injuries and the locations of injuries were compared.

Eligibility criteria: Inclusion Criteria:

* All of the injured in a snow season at a snow resort

Exclusion Criteria:

* None

Primary outcomes:
measure: Injury rate during the snow season
timeFrame: Injury rate during a snow season,an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01529528: A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients
Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Therapeutic Confirmatory Trial(Phase 3) to Evaluate Efficacy and Safety of CWP-0403 in Type 2 DM Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: CWP-0403
type 2 DM
Efficacy
Safety
Phase 3
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 117
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.


Eligibility criteria: Inclusion Criteria:

* Type 2 DM patients
* Subjects who couldn't control the blood glucose despite of a dietary and exercise therapy more than 6 weeks at screening visit
* FPG ≤ 270mg/dL at screening visit
* Patients who consent to participate in this trial by written Informed Consent Form

Exclusion Criteria:

* Type 1 DM or secondary diabetes
* Subjects who are administrating insulin or need to insulin therapy
* History of oral anti-hyperglycemic drugs within 6 weeks before screening visit
* Body mass index \< 20 kg/m2 or \> 40.0kg/m2
* Subjects who are assessed to be inappropriate for this trial by investigator

Primary outcomes:
measure: The Change in HbA1c from baseline to week24
timeFrame: 0wk, 8wk, 16wk, 24wk
Secondary outcomes:
measure: The proportion of subjects achieving HbA1c<6.5% at week24
timeFrame: 0wk, 8wk, 16wk, 24wk
measure: The proportion of subjects achieving HbA1c<7% at week24
timeFrame: 0wk, 8wk, 16wk, 24wk
measure: The change from baseline to week 24: Fasting plasma glucose
timeFrame: 0wk, 24wk
measure: change from baseline to week 24 in Fasting serum insulin
timeFrame: 0 wk, 24 wk
measure: change from baseline to week 24 in Fasting serum pro-insulin
timeFrame: 0 wk, 24wk
measure: change in from baseline to week 24 fasting serum c-peptide
timeFrame: 0wk, 24wk
measure: change from baseline to week 24 in HOMA-β
timeFrame: owjm 24wk
measure: change from baseline to week 24 in HOMA-IR
timeFrame: 0wk, 24 wk
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Sung Woo Park, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: