linjc16/ctgov huggingface dataset:
Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit

Study Overview
=================
Brief Summary
-----------------
This is a single-center study retrospectively evaluating a local clinical routine to administer norepinephrine in midline catheters, with regard to complications and patient outcomes

Detailed Description
-----------------
Se attached study protocol

Official Title
-----------------
Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit - a Retrospective Study of Complications and Patient Outcomes

Conditions
-----------------
Septic Shock, Norepinephrine Adverse Reaction, Hypotension and Shock

Intervention / Treatment
-----------------
* Drug: Norepinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Administration of norepinephrine in a midline catheter in an intermediary care unit In Skåne university hospital From 2019 to 2023-03-31 Exclusion Criteria: Patients who have actively disabled review of their electronic medical record

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Norepinephrine|Norepinephrine administered in midline catheter according to clinical routine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a major complication of norepinephrine administration in midline | extravasation of norepinephrine, midline-associated bloodstream infection, thrombosis | day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a minor complication of norepinephrine administration in midline | infiltration, occlusion of midline, dislodgement, leakage, other | day 30 | 
| Proportion of patients receiving a CVC after midline | Has the patient received central line after midline placement | day 30 | 
| Proportion of patients with different intermediary care unit outcomes | Where did the patient go after intermediary care? discharged / escalated to the ICU / deceased | day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasopressor, norepinephrine, septic shock, midline catheter, thrombosis, extravasation, catheter-related bloodstream infection
Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure.

Study Overview
=================
Brief Summary
-----------------
A multicenter, non-randomized prospective longitudinal study to evaluate the feasibility of Tricog's Remote platform for Guideline Directed Medical Therapy (GDMT) titration and remote patient monitoring among patients with Heart Failure.

Official Title
-----------------
Guideline Directed Medical Therapy (GDMT) Optimization and Adherence Longitudinal Study for Heart Failure. (GOALS-HF)

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Recent hospitalization (within 4 weeks of enrollment) for HF with IV diuretic use Echocardiographic data with EF measurements available in the last 6 months and after HF diagnosis Established outpatient care at the participating sites Eligible to receive at least 2 of the 4 GDMT classes (ACEi/ARB/ARNi, Beta-blockers, MRA, and SGLT2i) for HFrEF and HFmrEF and at least one of the three (ARB/ARNI, MRA, SGLT2i) for HFpEF Not on Target GDMT for all the eligible GDMT classes >12 months of expected survival Comfortable with spoken and written English communication Access to Apple Watch-compatible iPhone Exclusion Criteria: Under consideration for or recipient of advanced heart failure therapies (LVAD, Transplant) Current or anticipated use of home intravenous inotrope therapy. Unwilling or unable to perform all study related procedures (wear watch, take measurements and maintain daily logs) Post-discharge placement in nursing, rehabilitation, or long-term care facility Planned (within next 6 months) surgery Inability to provide written consent

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-ProBNP |  | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Diuretic Dose |  | 3-month, and 6-month follow-up | 
| HF hospitalizations |  | 3-month, and 6-month follow-up | 
| 6-min walk distance |  | 3-month, and 6-month follow-up | 
| KCCQ | KCCQ overall score, and sub-scores. | 3-month, and 6-month. | 
| Atrial Fibrillation Anticoagulation Utilization |  | 3-month, and 6-month | 
| HFpEF Medication Utilization |  | 3-month, and 6-month | 
| composite HF Collaboratory GDMT score |  | 3-month, and 6-month |
Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data

Official Title
-----------------
Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Conditions
-----------------
Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition Adult patients (>18 years) Exclusion Criteria: No informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous mitral valve repair<br>Patients undergoing percutaneous mitral valve repair under general anesthesia for mitral valve regurgitation. | |
| Surgical mitral valve repair or replacement<br>Patients undergoing surgical mitral valve repair or replacement for mitral valve regurgitation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial pressure waveform changes | Arterial pressure waveform as recorded by a continuous non invasive hemodynamic monitoring system. | Before and during general anesthesia for mitral valve repair or replacement, ranging from 1 to 5 hours. |
Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick

Study Overview
=================
Brief Summary
-----------------
We wish to examine Arterio-Venous Fistula (AVF) and Arterio-Venous Graft (AVG) utilisation rates for Haemodialysis at University Hospital Limerick. We want to determine out of the AVF's that are surgically created, how many go on to be used as anticipated for haemodialysis treatments successfully.

Detailed Description
-----------------
There are over 2 million end-stage renal disease (ESRD) patients who require renal replacement therapy worldwide, and this is estimated to rise to over 5 million by 2030 (Liyanage et al. 2015). Haemodialysis, used by the majority of ESRD patients, requires vascular access, where blood can be taken out of the body (via cannulation) and pumped through an external dialysis machine, which filters the blood of waste and excess fluid before being returned. Arterio-venous fistula creation is the preferred vascular access for haemodialysis, but has a large failure rate in the maturation period (Colley et al. 2022). Failure is usually attributed to insufficient dilation of the vessel and/or stenosis, which results in inadequate blood flow rates for the purpose of haemodialysis (Dixon, 2006). The purpose of this audit is to examine over a three year period how many of the individuals who had an AVF created are utilising it successfully for the purpose of haemodialysis as planned.

Official Title
-----------------
Arterio-Venous Fistula Audit. Successful Utilisation Rates of Arterio-Venous Fistulae for Haemodialysis at University Hospital Limerick

Conditions
-----------------
Arterio-venous Fistula

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had an AVF or AVG surgically created over the last three years at UHL who are undergoing haemodialysis treatments are suitable for inclusion. Dates for audit purposes are 1st April 2019 to 1st April 2022. Exclusion Criteria: Patients outside of these set dates will be excluded. Patients who are not currently undergoing haemodialysis treatments are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of AVF's created | We will determine how many were created surgically during the time frame. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AVF's in use for the purpose of Haemodialysis | We will dtermine how many are in use for haemodialysis as planned. | 3 years |
Molecular Signatures of Cutaneous Dupilumab Response

Study Overview
=================
Brief Summary
-----------------
This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.

Detailed Description
-----------------
This is a one-arm, open-label study to examine the effect of dupilumab. Dupilumab is a FDA-approved medication for the treatment of atopic dermatitis. This study will examine how dupilumab affects immune cells within atopic dermatitis skin lesions. Fifteen subjects with moderate to severe atopic dermatitis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict dupilumab treatment response.

Official Title
-----------------
Molecular Signatures of Cutaneous Dupilumab Response

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Dupilumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7 Exclusion Criteria: Known pregnancy Known immunodeficiencies Known parasitic infection -

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dupilumab treatment<br>Treatment with IL4RA inhibitor | Drug: Dupilumab<br>* dupilumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks | Change in EASI score from baseline to 8-12 weeks. Scores range from 0 to 72, with higher scores indicating more severity. | baseline and 8-12 weeks |
Low Grade Serous Ovarian Carcinoma and Uterine Involvement : Should Hysterectomy be the Rule

Study Overview
=================
Brief Summary
-----------------
Investigators studied a population of 28 low grade serous ovarian carcinoma treated in Hospices civils de Lyon between 2000 and 2022. The primary objective is to determinate the rate of myometrial involvement by the cancer at pathology examination. Then, investigators compared patients with or without myometrial involvement : survival parameters, predictive factors of myometrial involvement (age, CA 125 level, surgery characteristics, pathology characteristics).

Official Title
-----------------
LOw Grade Serous Ovarian Carcinoma and Uterine Involvement : Should hYSTerectomy be the Rule

Conditions
-----------------
Serous Ovarian Carcinoma, Low Grade Serous Ovarian Carcinoma

Intervention / Treatment
-----------------
* Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : 18 years old or more low grade serous ovarian cancer (MDACC classification) Grade 1 serous ovarian carcinoma (Silverberg classification) Exclusion Criteria : no sufficient data available grade 2 and 3 serous ovarian carcinoma
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Myometrial involvement<br>Myometrial involvement by cancer metastasis after pathology examination | Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.<br>* Presence of uterine myometrial metastasis at pathology examination after cytoreductive surgery<br>|
| No myometrial involvement<br>Absence of myometrial involvement by cancer metastasis after pathology examination | Other: Rate of myometrial involvement in the population of 28 low grade serous ovarian carcinoma.<br>* Presence of uterine myometrial metastasis at pathology examination after cytoreductive surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of myometrial involvement | Myometrial involvement after pathology examination | After pathology examination, average 2 to 3 weeks after cytoreductive surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Serous ovarian carcinoma, Low grade serous ovarian carcinoma, Fertility sparring surgery, Hysterectomy
Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Study Overview
=================
Brief Summary
-----------------
Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications. There is no agreement regarding the opportunity for a prophylactic simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract. The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.

Official Title
-----------------
Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Conditions
-----------------
Bicuspid Aortic Valve, Ascending Aorta Aneurysm

Intervention / Treatment
-----------------
* Procedure: Ascending aorta replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients; Bicuspid aortic valve; Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020; Untreated aortic valve disease of no more than moderate degree (<2+) at the time of ascending aorta surgery. Exclusion Criteria: Emergency/urgency procedures; Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery; Tricuspid aortic valve tricuspid; Absence of aortic valve disease; Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ascending aorta replacement|The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic valve regurgitation |  | Through study completion, a minimum of 6 months |
Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to explore the optimal target body temperature in first 24 hours and the relationship between body temperature and adverse outcomes of heat stroke. The main questions it aims to answer are: the optimal target body temperature at 0.5 h, 2 h, and the lowest body temperature of heat stroke. the best body temperature at the cutting point of stop cooling. The relationship between the volume and speed of ice saline infusion and the cooling effect.

Official Title
-----------------
Early Body Temperature Targets and Relationship With Prognosis in Patients With Heat Stroke

Conditions
-----------------
Heat Stroke

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years; ② diagnosed as heat stroke; ③ Informed consent from patients or family members. Exclusion Criteria: need immediate cardiopulmonary resuscitation; ② transferred from another hospital; ③ with severe underlying organ insufficiency; ④ pregnant women.

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 |
| --- | --- |
| Patients with heat stroke<br>Patients with heat stroke presenting to the emergency department at the study site | Other: observation<br>* This study is an observational study. Patients will receive conventional cooling measures and organ function support.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | Number of participants who dead during hospitalization | up to 90 days | 
| organ damage | Number of participants with organ damage, including but not limited to brain, lung, heart, kidney, liver and coagulation | up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous renal replacement therapy | Number of participants who need CRRT | up to 90 days | 
| length of ICU stay | The length patient stay in ICU | up to 90 days | 
| length of hospital stay | The length patient stay in hospital | up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heat stroke, body temperature, outcomes
Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Study Overview
=================
Brief Summary
-----------------
Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median & interquartile range (IQR)

Official Title
-----------------
Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Conditions
-----------------
Perianal Fistula, Perianal Crohn Disease, Anal Fissure, Rectovaginal Fistula, Perianal Fistula Due to Crohn's Disease

Intervention / Treatment
-----------------
* Procedure: Regenerative therapy with SVF-PRP to supplement perianal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Regenerative therapy with SVF-PRP to supplement perianal surgery|Regenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to supplement perianal surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Healing | Absence of fistula opening and discharge, well-being | 1 year | 
| MRI healing | Absence of active fistula and abscess | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal continence | Vaizey score | 1 year | 
| Quality of life (general and related to perianal diseases) | FIQoL | 1 year | 
| Costs | Direct cost to patient, institution, and payee | 1 year |