louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03915717: Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
Official title: Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Free Flap Transfer
Malignant Neoplasm
Lead sponsor: Sonavex, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing free flap surgery

Brief summary: The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
* Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
* Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

* Age \<18 years old
* Patient unable to sign informed consent
* Patient participating in another investigational device or pharmacological study
* Prisoner or patient from vulnerable populations as defined in 45 CFR 46.

Primary outcomes:
measure: Surgeon Evaluation of Improved Monitoring Ability Via Questionnaire With Likert Scale
timeFrame: Through study completion
measure: Surgeon Evaluation of Satisfaction
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Flap Failure Rate
timeFrame: Through patient stay, up to 5 days post-op
measure: Flap Takeback Rate
timeFrame: Through patient stay, up to 5 days post-op
measure: Flap Salvage Rate
timeFrame: Through patient stay, up to 5 days post-op
measure: Total Cost of Hospitalization
timeFrame: Through patient stay, up to 5 days post-op
measure: Time From OR Departure to Return to OR
timeFrame: Through patient stay, up to 5 days post-op
measure: Nurse Evaluation of Improved Monitoring Via Questionnaire With Likert Scale
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02942524: Checklist Tool in Engaging Patients in the Discharge Planning Process
Official title: Tool to Engage Patients in Discharge (TEPID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization
Malignant Neoplasm
Transitional Care Planning
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 450
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial studies how well a checklist tool works in engaging patients in the discharge planning process. Engaging patients in the discharge process may increase participation in the discharge process and improve discharge outcomes, understanding of care after hospitalization, and decrease complications.

Detailed description: PRIMARY OBJECTIVES:

I. Measure the impact on discharge and transition satisfaction of utilizing questions from the Consumer Assessment of Healthcare Providers and Systems (CHAPS) patient satisfaction survey.

II. Measure the impact of the Tool to Engage Patients in Discharge (TEPID) on patient's Readiness for Hospital Discharge and Problems After Discharge Questionnaire-English (PADQ-E) results.

III. Measure the impact on decreasing healthcare utilization measures: readmission rates within 30 days from hospital discharge, hospital length of stay of admission in hospital, and emergency department visits within 30 days of hospital discharge.

OUTLINE:

Patients complete the TEPID checklist of items during hospital stay.

After completion of the study, patients are followed up for 35 days.

Eligibility criteria: Inclusion Criteria:

* Patients fluent in English, conscious, coherent, and alert or have an adult caregiver present that is fluent in English will be identified for the TEPID research project

Exclusion Criteria:

* Patients discharged to another inpatient facility (hospice, skilled nursing facility, long term acute care hospital \[LTACH\], or acute rehab) or patients discharged home with hospice will be excluded
* Any patients that are transferred to another unit prior to discharge will be excluded

Primary outcomes:
measure: Average score from the PADQ-E
timeFrame: Up to 12 months
measure: Average score from the Readiness for Hospital Discharge Scale
timeFrame: Up to 12 months
measure: Emergency department visits
timeFrame: Up to 12 months
measure: Patient satisfaction as measured by the Press Ganey Consumer Assessment of Healthcare Providers and Systems Survey
timeFrame: Up to 12 months
measure: Readmission rates
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Lisa Graham
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03355924: DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure
Official title: DMEK And Cataract Surgery: Comparison Of Sequential Versus Combined Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Corneal Graft
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 31
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: patients who underwent DMEK combined or not with cataract surgery

Brief summary: The aim of this study is to describe the outcomes of phaco-DMEK (Descemet Membrane Endothelial Keratoplasty ) according to a sequential versus a combined procedure

Detailed description: The study included patients who underwent DMEK combined or not with cataract surgery between January 2014 and march 2016. Were excluded patients with other ocular comorbidity, and those who had graft after a first graft failure. The main outcome was BVCA measured at one year. The post-operative follow up was down at D7, M1, M3, M6, and M12. Secondary outcomes were; the mean time to visual recovery and influence of the delay between cataract removal and DMEK.

Eligibility criteria: Inclusion Criteria:

* patients who underwent DMEK combined or not with cataract surgery

Exclusion Criteria:

* patients with other ocular comorbidity, and those who had graft after a first graft failure

Primary outcomes:
measure: Best visual acuity
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03621124: Maladaptive Adipose Tissue Activity in Cancer
Official title: Maladaptive Adipose Tissue Activity in Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer Nos
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-08-08
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients equal to or greater than forty years of age with an active cancer diagnosis.

Brief summary: The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.

Detailed description: The purpose of this research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Many patients affected by cancer lose weight, despite normal or increased nutrition. It may progress to the condition called "cancer-associated cachexia." Cancer associated cachexia is defined by an ongoing loss of skeletal muscle mass with or without the loss of fat mass, and may negatively affect quality of life and the ability to undergo cancer treatments. Metabolism is the breakdown of food by the body into the energy that your body needs.

Eligibility criteria: Inclusion Criteria:

* ≥ 40 years of age
* Have active cancer diagnosis.
* Have had a PET/CT scan within the past 12 months at time of enrollment.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Current use of beta-blockers
* Women who are pregnant or unsure of their pregnancy status
* Women who are breastfeeding
* Suffers from severe claustrophobia
* Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
* In remission stage for cancer diagnosis

Primary outcomes:
measure: Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.
timeFrame: 27 Months
Secondary outcomes:
measure: Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.
timeFrame: 27 Months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/ Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Francesco S Celi, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00915824: Prevention of Potentially Inappropriate Prescribing in Late Life Using Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and Screening Tool to Alert Doctors to Right Treatment (START) Criteria
Official title: Prevention of Potentially Inappropriate Prescribing in Late Life Using STOPP (Screening Tool of Older Persons' Potentially Inappropriate Prescriptions) and START (Screening Tool to Alert Doctors to Right i.e. Appropriate Indicated Treatment): A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Keywords: Drug therapy
Prescribing
Appropriateness
Randomized controlled trial
STOPP/START criteria
Appropriateness of prescribing in older patients
Prescription Drugs
Lead sponsor: Cork University Hospital
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Potentially inappropriate prescribing is common in older patients and encompasses overuse, misuse and underuse of medications. Potentially inappropriate prescribing is associated with negative outcomes including adverse drug events and hospitalization.

STOPP (Screening Tool of Older Person's potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) is a new screening tool designed to detect instances of potentially inappropriate medication use and under-prescribing of clinically indicated medications in older patients. The purpose of this study is to determine whether clinical implementation of STOPP/START criteria in hospitalized older patients is effective in improving prescribing quality.


Eligibility criteria: Inclusion Criteria:

* All patients aged 65 years and older admitted to the general medical services of Cork University Hospital, Cork, Ireland

Exclusion Criteria:

* Patient admitted to a geriatric medicine service, psychiatry of old age service or clinical pharmacology service, or under review of these services during the previous 12 months
* Critically ill patient (admitted to the intensive care unit)
* Terminally ill patient
* Refusal of patient or hospital physician to participate
* No time for the research physician to enrol the patient within 3 days of admission

Primary outcomes:
measure: Appropriateness of prescribing using the Medication Appropriateness Index and the Assessment of Underutilization of Medication Tool
timeFrame: Measured on admission, discharge and at 2, 4 and 6 months post-discharge
Secondary outcomes:
measure: Composite health resource utilization including hospital readmission and primary care consultations
timeFrame: at 2, 4 and 6 months post-discharge
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
Study officials:
affiliation: Cork University Hospital
name: Paul Gallagher, MB MRCPI
role: PRINCIPAL_INVESTIGATOR
affiliation: Cork University Hospital
name: Denis O'Mahony, MD FRCPI
role: STUDY_DIRECTOR
References:
Clinical trial NCT01937624: Pediatric Distal Radius US Study
Official title: Pediatric Distal Radius US Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fractures
Keywords: Diagnostic ultrasound
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with wrist injury

Brief summary: The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.


Eligibility criteria: Inclusion Criteria:

* Pediatric patient with a wrist injury.

Exclusion Criteria:

* Gross deformity of the injured body part, suspected open fractures and the need for emergent surgery

Primary outcomes:
measure: Presence of Fracture
timeFrame: Duration of office visit
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
state: South Carolina
Study officials:
affiliation: Steadman Hawkins Clinic of the Carolinas - Greenville Hospital System
name: Kyle Cassas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04085224: 6x3 Crossover, Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Official title: A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between the ages of 19 or more and less than 40 years (19 =\< age \< 40) on the day of screening
* Negative findings in serum / urine hCG test or Subjects who are not pregnant or lactating in women

Exclusion Criteria:

* Administered other drug(s) in other clinical study within 180 days prior to the day of screening

Primary outcomes:
measure: Bioavailability
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT02067624: Effects of Thai Massage on Patients With Wrist Extensor Muscles Latent Myofascial Trigger Points
Official title: Effects of Thai Massage on Patients With Wrist Extensor Muscles Latent Myofascial Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Latent Myofascial Trigger Point
Lead sponsor: Mae Fah Luang University Hospital
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effect of Thai massage on pressure pain threshold, pain intensity, wrist range of motion, grip strength and patient satisfaction in patients with wrist extensor muscles latent Myofascial trigger points.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age between 18 - 40 years old
* The participants have at least one latent trigger point in the wrist extensor groups muscles.
* The participants will be able to follow instructions.
* Good communication and cooperation.

Exclusion Criteria:

* Contraindications of traditional Thai massage
* Tennis elbow or Golf's elbow
* Poor skin sentation

Primary outcomes:
measure: Pressure Pain Threshold as a measure by algometry
timeFrame: 5 weeks
Secondary outcomes:
measure: Pain scores on visual analog scale
timeFrame: 5 weeks
measure: Wrist Range of motion as a Measure by goniometer
timeFrame: 5 weeks
measure: Grip strength as a measure by hand-held dynamometer
timeFrame: 5 weeks
measure: Patient satisfaction level
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mueang
country: Thailand
facility: School of Health Science, Mae Fah Luang University
state: Chiang Rai
Study officials:
References:
Clinical trial NCT01695824: Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation
Official title: Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: catheter ablation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2012-09-28
Enrollment: 96
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: The primary objective of this study is to assess combined end point (All stroke, Systemic embolism, Cardiovascular death) between two groups.


Eligibility criteria: Inclusion Criteria:

* Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
* Eligible for long term warfarin
* CHADS score \>= 1 (congestive heart failure \[CHF\], history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack \[TIA\])

Exclusion Criteria:

* Contraindicated for warfarin
* Contraindicated for aspirin or clopidogrel (Plavix)
* CHF Class 4
* Implanted mechanical valve
* Atrial septal or Patent Foramen Ovale (PFO) device
* Platelets \< 100,000 or hemoglobin \< 10
* Left ventricular ejection fraction (LVEF) \< 30%

Primary outcomes:
measure: All stroke
timeFrame: 12 months
measure: Systemic embolism
timeFrame: 12 months
measure: Cardiovascular death
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 45 days
measure: Procedure success
timeFrame: 45 days
measure: 30 day major adverse event (MAE)
timeFrame: 30 days
measure: Left atrial appendage (LAA) coverage
timeFrame: 45 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romanov A, Pokushalov E, Artemenko S, Yakubov A, Stenin I, Kretov E, Krestianinov O, Grazhdankin I, Risteski D, Karaskov A, Steinberg JS. Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial. J Interv Card Electrophysiol. 2015 Oct;44(1):9-16. doi: 10.1007/s10840-015-0030-4. Epub 2015 Jul 2.
Clinical trial NCT00638924: Physiologic Variables in Healthy Women in Shuttle Walk Test
Official title: Analysis of Physiologic Variables in Healthy Women in Shuttle Walk Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: healthy sedentary women
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women, between 20 and 30 years old, healthy and sedentary

Brief summary: To analyze the alterations of physiologic variables in healthy sedentary women in the Shuttle Walk Test, verify the distance reached and interruption causes of the test.

Detailed description: The Shuttle Walk Test requires patients to walk at a gradually increasing speed, up and down a 10 meter corridor identified by two marker cones, until they reach a symptom limited maximum. The walking speed was externally paced and controlled by a series of beeps played on a compact disk.

Eligibility criteria: 1. Inclusion criteria:

   1. female gender;
   2. sedentary;
   3. aged 20 to 30 years.
2. Exclusion criteria:

   1. pregnancy;
   2. enrolment in any regular physical activity program;
   3. diagnosed health conditions.

Primary outcomes:
measure: Shuttle Walk Test Distance
timeFrame: baseline
Secondary outcomes:
measure: Heart Rate
timeFrame: baseline
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: State University of Campinas
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Ivete Alonso Saad, dr
role: STUDY_CHAIR
References: