linjc16/ctgov huggingface dataset:
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure

Study Overview
=================
Brief Summary
-----------------
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink in Conexus-enabled devices (remote arm) as compared to the same devices without Medtronic OptiVol, Medtronic CareAlerts and Medtronic CareLink available to the treating physician (standard arm).

Official Title
-----------------
Clinical Evaluation to Assess the Effect of the Combination of a Pre-Defined Management Pathway to Reduce Fluid Overload in Cardiac Decompensation With Carelink Remote Management, Connexus Remote Telemetry and the OptiVol Early Warning System on Health Care Utilization

Conditions
-----------------
Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization

Intervention / Treatment
-----------------
* Behavioral: Device triggered remote telephone contact because of Care Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Implantation of a market-approved Medtronic Connexus CRT-D- or DR-ICD-device Patient consents to study Ability to replace follow-ups with CareLink follow-ups Ability to attend all follow-ups at study center Exclusion Criteria: Permanent AF Less than 18 years of age Life expectancy less than 15 months Participation in another clinical study Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Remote Arm (OptiVol plus Connexus Telemetry plus CareLink plus Intervention Algorithm), Clinical Management Alerts ON | Behavioral: Device triggered remote telephone contact because of Care Alert<br>* Care Alerts on, physician will be notified in case of an Care Alert. Depending on the outcome of the telephone contact drug adjustment and / or further interventions can be prescribed<br>* Other names: Medtronic Virtuoso;|
| No Intervention: 2<br>No Care Alerts available, standard treatment of the patient | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first hospitalization due to worsened heart failure |  | 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from device detected onset of arrhythmias, cardiovascular disease progression and system issues to clinical decision making |  | 15 months |
The Use of Compression Bandages in Total Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The use of compression bandages in elective orthopaedic knee surgery is well regarded, however, there is a lack of robust, well-designed evidence to support this. The aim is to determine the feasibility of conducting a randomised control trial comparing the use of a compression bandage worn post-operatively for 24 hours after elective total knee replacement, compared to standard practice (wool and crepe, non-compressive dressing).

Official Title
-----------------
A Prospective, Randomised Control Trial Investigating the Use of a Two-layer, Short-stretch Compression Bandage in Elective Total Knee Replacement - Feasibility

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Actico, short-stretch, inelastic dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Able to give written, informed consent Primary total knee replacement Exclusion Criteria: Extensive peripheral vascular disease Lower limb neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine care<br>Wool and crepe bandage for 24 hours post-operatively | |
| Experimental: Compression bandage<br>Actico, inelastic, short-stretch compression bandage worn 24 hours post-operatively | Procedure: Actico, short-stretch, inelastic dressing<br>* Worn 24hr post-operatively<br>* Other names: Compression bandage;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | Additionally, the study is a feasibility study to estimate (via the pilot trial) rates of patient recruitment, randomisation, retention and response, logistics of trial methodology, and resource utilisation. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee range of motion | Range of motion of the knee compared to the pre-operative knee. | 6 months | 
| Pain | Post-operative pain scores measured by visual analogue scale | 6 months | 
| Patient satisfaction | Oxford knee score and EQ-5D scores pre-operatively and at six months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Total knee replacement, Enhanced recovery, Compression bandages
Local Application of Autologous Bone Marrow Cells for Treatment of Chronic Diabetic Ulcers

Study Overview
=================
Brief Summary
-----------------
Bone marrow cells were previously shown to enhance wound healing in experimental diabetes. In this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.

Conditions
-----------------
Diabetic Foot, Diabetes Complications

Intervention / Treatment
-----------------
* Procedure: Application of autologous bone marrow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus chronic non-healing foot ulcers (>4weeks) Exclusion Criteria: Charcot foot Non-diabetic ulcers Ulcers healing under conventional therapy Sepsis Hematologic disorders Pregnancy Acute inflammatory disorders Chemotherapy
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Application of autologous bone marrow|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Feasibility |  |  | 
| Healing velocity |  |  |
Tylenol Levels in Bariatric Patients

Study Overview
=================
Brief Summary
-----------------
The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.

Detailed Description
-----------------
This will be a descriptive study carried out by study staff from the anesthesiology department. The patient population will include obese patients scheduled for robot-assisted or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for these patients. Volume of distribution and elimination half-life of acetaminophen in serum samples are the primary measurements of the study. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.

Official Title
-----------------
Acetaminophen Pharmacokinetics in Bariatric Patients

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 12, but younger than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery American Society of Anesthesiologists Physical Status Classification System (ASA) I, II or III Parent/guardian willing and able to give consent Patient willing to give assent, or consent Patients that are otherwise healthy at the discretion of the study staff Patients with BMI >95th percentile Exclusion Criteria: Patients with severe right heart failure or severe asthma Patients with deficient hepatic function that can affect drug metabolism Systemic steroid use within the last 3 months Patients who have taken acetaminophen containing medications within 24 hours of surgery date Patients younger than 12, but older than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery Patients having other procedures in addition to robotic assisted or laparoscopic bariatric surgery American Society of Anesthesiologists Physical Status Classification System (ASA) IV and above Females testing positive for pregnancy Parent/guardian not willing and able to give assent, or consent Patient not willing to give assent, or consent Patients with BMI < 95th percentile

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and Post-operative Serum Concentrations | To determine whether adequate serum concentration of acetaminophen is achieved. | 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Bariatrics, Acetaminophen, robot-assisted or laparoscopic bariatric surgery, Pharmacokinetics
Transumbilical Versus Transvaginal Specimen Retrieval at Minilaparoscopy

Study Overview
=================
Brief Summary
-----------------
We hypothesise that pain at minilaparoscopy for gynecologic disease is reduced when transvaginal rather than transumbilical specimen extraction is accomplished. This would be due to the avoidance of a 10-mm port in the umbilicus. Visual analogue scale score of post-operative pain will be obtained and patients satisfaction will be asked at the 2-month postoperative visit.

Conditions
-----------------
Postoperative Pain, Patients Satisfaction, Intraoperative Complications, Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: TRANSVAGINAL SPECIMEN EXTRACTION
* Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adnexal Mass Benign Gynecologic Condition Laparoscopicb Surgery Exclusion Criteria: Obliteration Of The Douglas Pouch
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRANSVAGINAL EXTRACTION<br> | Procedure: TRANSVAGINAL SPECIMEN EXTRACTION<br>* Transvaginal specimen retrieval following posterior colpotomy<br>|
| Active Comparator: TRANSUMBILICAL EXTRACTION<br> | Procedure: TRANSUMBILICAL SPECIMEN EXTRACTION<br>* Transumbilical specimen retrieval following enlargement of the umbilical port<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain |  | 3 months |
Soluble ST2 and Cardiovascular Outcome

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery induces hemodynamic stress on the myocardium, and this process can be associated with significant cardiovascular morbidity and mortality. Soluble suppression of tumorigenicity 2 (sST2) is biomarker of myocardial remodeling and fibrosis; however, little is known regarding their potential association with cardiovascular events. This study aimed to investigate the release of sST2 and its association with cardiovascular events undergoing cardiac surgery.

Official Title
-----------------
Association Between Soluble ST2 and Cardiovascular Outcome After Cardiovascular Surgery

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Diagnostic Test: soluble ST2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years Congenital heart disease requiring surgery Valvular heart disease requiring surgery Arrhythmia requiring surgery Aortic dissection requiring surgery Coronary heart disease requiring surgery Exclusion Criteria: age <18 years pregnancy severe renal dysfunction (creatinine >200µmol/L) not capable of understanding or signing informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: soluble ST2|Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Number of participants death of 30 days after surgery | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure | requiring initiation or change in heart failure medication or requiring hospitalisation | 30 days after surgery |
In-Field Detection of Intracranial Pressure

Study Overview
=================
Brief Summary
-----------------
This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.

Official Title
-----------------
In-Field Detection of Acute Intracranial Hemorrhage Requiring Urgent, Life-Saving Treatment in Severe Traumatic Brain Injury (TBI) Patients

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Other: Optic Nerve Ultrasounds


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy Volunteer Inclusion Criteria: Adults 18 or older Able to provide legally effective consent Healthy Volunteer Exclusion Criteria: Intracranial disease, neurologic symptoms, or eye pathology Patient Inclusion Criteria: Adults age 18 or older Confirmed or suspected severe traumatic brain injury Able to provide legally effective consent Patient Exclusion Criteria: Significant bilateral ocular trauma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Volunteers<br> | Other: Optic Nerve Ultrasounds<br>* Patients will have up to four ultrasounds of the optic nerve.<br>|
| Experimental: Traumatic Brain Injury Patients<br> | Other: Optic Nerve Ultrasounds<br>* Patients will have up to four ultrasounds of the optic nerve.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optic nerve sheath diameter | Develop software that will automatically measure optic nerve sheath diameter by analyzing the radio frequency data from an ultrasound probe intervention from those that do not, we will measure the optic nerve sheath diameter manually in the cross-sectional images. | Approximately 10 minutes at the time of ultrasounds |
Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection

Study Overview
=================
Brief Summary
-----------------
A single-center prospective study. Patients undergoing surgery for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.

Official Title
-----------------
Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection

Conditions
-----------------
Aortic Dissection

Intervention / Treatment
-----------------
* Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device
* Procedure: Surgical cut-down and arterial puncture under direct vision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden. Exclusion Criteria: Non-femoral arterial cannulation Concomitant femoro-femoral bypass Conversion to ECMO with arterial inflow in the previously cannulated femoral artery Death within 30 days from procedure Loss to follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention/treatment Surgical cut-down and arterial puncture under direct vision<br>Surgical cut-down and arterial puncture under direct vision. | Procedure: Surgical cut-down and arterial puncture under direct vision<br>* Surgical cut-down and arterial puncture under direct vision.<br>|
| Percutaneous arteriotomy closed with closure device<br>Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). | Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device<br>* Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral access site complication | Seroma, wound infection, or nerve injury | During the first 8 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral artery complication | Pseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure | During the first 3 years after surgery |
The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.

Detailed Description
-----------------
Venous thromboembolic (VTE) prophylaxis in trauma patients is a critical clinical problem. Patients with traumatic brain injury usually have effective VTE prophylaxis withheld secondary to concerns of exacerbating intracranial hemorrhage. This study examines the safety and efficacy of early administration (within 24 hrs of admission) of low molecular weight heparin to this patient population with very high VTE risk.

Official Title
-----------------
The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

Conditions
-----------------
Brain Injury, Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: Enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blunt traumatic brain injury (Marshall II-V) Stable 6 hr. head CT Stable hemoglobin Exclusion Criteria: Premorbid coagulopathy Pregnancy < 18 y.o. Need for therapeutic anticoagulation Heparin allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enoxaparin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enoxaparin, Safety