linjc16/ctgov huggingface dataset:
Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.

Detailed Description
-----------------
Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Nafamostat mesilate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were admitted to the intensive care unit and required CRRT active bleeding such as gastrointestinal bleeding and intracranial hemorrhage, activated partial thromboplastin time > 60 s, prothrombin time-international normalized ratio > 2.0, thrombocytopenia (<100,000/µL), and surgery within 48 h before CRRT. Exclusion Criteria: Pregnant or possibly pregnant women Patients who were allergic to nafamostat mesilate Patients who were hypercoagulable

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 |
| --- | --- |
| Active Comparator: Nafamostat mesilate group<br>Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy. | Drug: Nafamostat mesilate<br>* nafamostat mesilate use for anticoagulation<br>* Other names: Futhan;|
| Placebo Comparator: No anticoagulation group<br>Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy. | Drug: Normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of filters used per hour |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea reduction ratio |  | 24 months | 
| Survival rate |  | 24 months |
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

Study Overview
=================
Brief Summary
-----------------
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.

Official Title
-----------------
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)

Conditions
-----------------
Metastatic Castration-resistant Prostate Cancer

Intervention / Treatment
-----------------
* Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated informed consent form Male ≥ 18 years of age Patients meeting clinical need for Illuccix PET scan: Patients with suspected metastasis who are candidates for initial definitive therapy Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level Patient is physically able to lay flat for the PET-CT procedure Exclusion Criteria: 1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose<br>3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. | Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT<br>* Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11<br>|
| Experimental: High dose<br>7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time. | Drug: illuccix 68Ga-PSMA-11 Total Body PET-CT<br>* Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths. | In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length. | 3 months |
Is Laparoscopic Fundoplication Better Than Open Fundoplication in Children ?

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to compare short- and longterm outcomes after laparoscopic and open Nissen fundoplication in children.

Official Title
-----------------
IS Laparoscopic Fundoplication Superior to Open Fundoplication in Children - a Randomized Study

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Procedure: Fundoplication
* Procedure: Fundoplication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0-15 years All patients accepted for primary fundoplication at Oslo University Hospital Exclusion Criteria: Age over 16 years Parents not speaking Norwegian or English well Prior fundoplication Patients with comorbidities considered as unsuited for laparoscopic surgery (diaphragma hernia, several previous abdominal operations etc)

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| Active Comparator: Open fundoplication<br>Fundoplication performed with open surgery | Procedure: Fundoplication<br>* Primary fundoplication<br>* Other names: Gastroesophageal reflux;|
| Experimental: Lap fundoplication<br>Primary fundoplication performed by laparoscopic surgery | Procedure: Fundoplication<br>* Primary fundoplication<br>* Other names: Gastroesophageal reflux;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of reflux | GER symptoms and GER on pH monitoring. Need for redo fundoplication. PPI. | 12, 24 and 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate | Perioperative complications. Duration of surgery. Postoperative complications. Lenght of hospital stay. Readmission to hospital. | 30 days | 
| Inflammatory response | indicies of inflammatory response | The first 4 p.o days | 
| Parental stress | Indicies of parental stress caused by GER pre- and postoperatively | 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Gastroesophageal Reflux, Fundoplication, Randomized Controlled Trial, General Surgery, Laparoscopy
Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia

Study Overview
=================
Brief Summary
-----------------
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by severe, unusual headaches associated with multifocal segmental vasoconstriction of the intracerebral arteries. In addition to headache, focal neurological deficit and/or seizures are quite frequently described, but anterograde amnesia seems to but extremely rare. Indeed, to date, only one case of RCVS associated with transient global amnesia (TGA) has been published. In case of an atypical presentation of TG, associated with brutal headaches, it is important not to ignore an assocation with RCVS because management, treatment, evolution and prognosis are different. Indeed, TGA is a monophasic phenomenon of less than 24 hours duration, without associated complications, which does not require any particular treatment. On the other hand, RCVS, although most often of excellent prognosis, can have severe complications such as intracerebral hemorrhage, subarachnoid hemorrhage, posterior reversible encephalopathy syndrome and cerebral infarction. In order to limit headaches and potential complications, RCVS require special management, including symptomatic treatments for headaches, complete rest, removal of precipitin factors and introduction of calcium channel blockers for a few weeks. This study aim to described three cases of patient who presented with concomitant TGA and RCVS, and to discuss pathogenic mechanism which may be similar in both these pathologies.

Official Title
-----------------
Reversible Cerebral Vasoconstriction Syndrome With Concomitant Transient Global Amnesia : a Serie of 3 Cases Report

Conditions
-----------------
Transient Global Amnesia, Reversible Vasoconstriction Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a proven or probable RCVS concomitant with certain transient global amnesia Exclusion Criteria: Not proven transient global amnesia, not proven or possible RCVS

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 |
| --- | --- | --- |
| Occurrence of concomitant TGA and proven RCVS | Occurrence of concomitant transient global amnesia (TGA) and proven Reversible cerebral vasoconstriction syndrome (RCVS) | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thunderclap headache
Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

Study Overview
=================
Brief Summary
-----------------
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the Ganglion Cell Analysis (GCA) average thickness.

Detailed Description
-----------------
To determine the area under the Receiver Operator Characteristic Curve (AUC) for the following GCA parameters: Minimum thickness Supero-temporal thickness Superior thickness Supero-nasal thickness Infero-temporal thickness Inferior thickness Infero-nasal thickness

Official Title
-----------------
Macular Ganglion Cell Analysis (GCA) of the Cirrus HD-OCT in Glaucoma

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 40 years or older Diagnosed to have glaucoma by the Principal Investigator or co-investigator Able and willing to make the required study visits Able and willing to give consent and follow study instructions Exclusion Criteria: Ophthalmic: Best corrected visual acuity in either eye worse than 20/40 on a Snellen chart or on a Snellen equivalent acuity chart. Refractive error outside -12.00D to +8.00D spherical range or >-3.00D cylinder. Previous vitreoretinal surgery in study eye. Vitreoretinal traction or epiretinal membrane in the study eye. Any active infection of anterior or posterior segments. Evidence of diabetic retinopathy, diabetic macular edema, or other vitreoretinal disease in the study eye upon dilated examination, or upon evaluation of retinal photos. Systemic: History of diabetes, leukemia, AIDS, uncontrolled systemic hypertension, dementia or multiple sclerosis. A life threatening or debilitating disease. Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE). Current or recent (within the past 14 days) use of an agent with photosensitizing properties by any route (e.g., Visudyne®, ciprofloxacin, Bactrim®, doxycycline, etc.). Concomitant use of hydrochloroquine and/or chloroquine.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Glaucoma<br>subjects with glaucoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the area under the Receiver Operator Characteristic Curve (AUC) for the GCA average thickness, and 7 more GCA parameters. |  | Study was released before December 1, 2012 |
Medtronic Reveal XT Study

Study Overview
=================
Brief Summary
-----------------
While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative arrhythmia burden following surgical treatment for AF in patients undergoing either lone or concomitant heart surgery.

Official Title
-----------------
A Comparison of Traditional Arrhythmia Assessment With the Use of Continuous Monitoring to Quantify Postoperative Arrhythmia Burden Following Surgical Treatment of Atrial Fibrillation- Medtronic Reveal XT Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Reveal XT implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing planned, elective AF surgery, either as a stand-alone procedure or as a concomitant cardiac operation. Patients will have either a Cox-Maze procedure (full-biatrial lesion set) or surgical pulmonary vein isolation (PVI). Patients 18 years or older. All eligible patients will be considered, regardless of gender or race. Patients able and willing to provide informed consent and willing to comply with the required interval follow-up. Exclusion Criteria: Patients with a preoperative permanent pacemaker. Patients with a projected lifespan of less than six months. Patients requiring emergent cardiac surgery. Patients unwilling or unable to give written informed consent. Patients undergoing a right atrial or left atrial lesion set procedure.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reveal XT<br> | Device: Reveal XT implantation<br>* The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals |  | ILR monitoring obtained at 3, 6 and 12 months | 
| Freedom From Atrial Tachyarrhythmias (ATAs) |  | ILR monitoring at 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients
Plantar Plate Repair for Treatment of Floating Toe: Must we Associate it to Weil Osteotomy?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess if isolated Weil osteotomy for floating toe grade II or III provides results that are not inferior to those obtained with the Weil osteotomy associated with plantar plate repair.

Official Title
-----------------
Plantar Plate Repair for Treatment of Floating Toe: Must we Associate it to Weil Osteotomy?

Conditions
-----------------
Floating Toe

Intervention / Treatment
-----------------
* Procedure: Weil osteotomy
* Procedure: Plantar plate repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old, minimum ability to understand treatment and recovery floating toe Exclusion Criteria: age less than 18 years old at the moment of recruiting patients who are not able to understand treatment and recovery intraoperative diagnosis of plantar plate injury grade 0, I or IV in Nery's classification secondary surgery

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>Weil osteotomy and plantar plate repair | Procedure: Weil osteotomy<br>* Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.<br>Procedure: Plantar plate repair<br>* Plantar plate reconstruction at metatarsophalangeal area, using sutures.<br>|
| Experimental: intervention<br>Weil osteotomy alone | Procedure: Weil osteotomy<br>* Open, oblique, distal osteotomy of the metatarsal bone, with screw fixation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manchester-Oxford Foot Questionnaire (MOXFQ) score at the end of follow-up | Score obtained at Manchester-Oxford Foot and Ankle Questionnaire (0-100, where higher scores mean a worse outcome) one year after surgery. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age |  | moment of recruiting | 
| sex |  | moment of recruiting | 
| side | left or right foot | moment of recruiting | 
| rate of recurrence |  | 1 month, 3 months, 6 months, 1 year after surgery | 
| rate of complications | related to surgery | 1 month, 3 months, 6 months, 1 year after surgery | 
| Score obtained at Manchester-Oxford Foot and Ankle Questionnaire (0-100, where higher scores mean a worse outcome) |  | 3 months, 6 months after surgery |
Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.

Detailed Description
-----------------
Methods: Prospective interventional randomized double blind placebo controlled study. Intervention: Hydrocortisone in stress doses vs. placebo Patients: 92 high risk patients after cardiac surgery Measurements: Cytokines, Toll-like receptors, NF kappa B, outcome data, health care related quality of life, PTSD.

Official Title
-----------------
Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery

Conditions
-----------------
Systemic Inflammatory Response Syndrome, Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: Hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min Exclusion Criteria: Pregnancy Severe liver insufficiency Severe renal insufficiency Insulin dependent diabetes mellitus Steroid therapy Psychiatric disease
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br> | Drug: Hydrocortisone<br>* Hydrocortisone<br>* Other names: Stress doses of hydrocortisone;|
| Active Comparator: B<br>Stress doses of hydrocortisone | Drug: Hydrocortisone<br>* Hydrocortisone<br>* Other names: Stress doses of hydrocortisone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunologic markers, health care related quality of life, PTSD |  | one and a half year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early clinical outcome parameters (LOS in the ICU) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac surgery, systemic inflammatory response syndrome, health-related quality of life