linjc16/ctgov huggingface dataset:
The Effect of General Anesthesia on the Risk for Arrhythmia

Study Overview
=================
Brief Summary
-----------------
Polymorphic ventricular tachycardia, known as Torsades de Pointes (TdP), is a specific form of ventricular arrhythmia with a characteristic twist of the QRS complex around the isoelectric baseline. TdP can degenerate into ventricular defibrillation followed by sudden cardiac death. A predictor for the development of TdP is the length of the QT interval measured on an EKG recording. The QT interval is known to be prolonged by many medications used in a perioperative setting as well as by other conditions such as hypothermia and electrolyte imbalance. General anesthesia exposes most of the investigators patients to a combination of several of those medications and conditions and therefore might increase the risk for the development of QT prolongation. Moreover, patient related risk factors are well known and aggravate the individual risk for potential life threatening TdP events when exposed to QT prolonging medications perioperatively. Previous research suggests that more than 20% of the patients might develop QT prolongations perioperatively and are consequently on an increased risk for TdP; yet, no study has systematically investigated the magnitude of the problem and associated risk factors. The proposed pilot study is designed as a prospective observational cohort study to investigate the QT interval before, during and after general anesthesia. It aims to determine the incidence of perioperative QT prolongations. A customary long term EKG recording device will be connected to a random sample of patients undergoing general anesthesia. Using these continuous EKG tracings, the lengths of the QT interval will be analyzed during the perioperative period.

Official Title
-----------------
The Effect of General Anesthesia on the Risk for Arrhythmia -A Pilot Study

Conditions
-----------------
Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female ASA I - III patients Age 18 years and older Scheduled for general anesthesia with a duration of at least 1 hour Exclusion Criteria: Cardiac or thoracic surgery Planed postoperative ICU admission Non-English speaking Not in sinus rhythm Left and right bundle branch block Implanted pacemaker Mentally impaired

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
general anesthesia, electrocardiography, long QT syndrome, acquired
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

Study Overview
=================
Brief Summary
-----------------
The study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertension(CHD-PAH) from the investigator's hospital. The main aim of the study is to describe the aetiology, natural history and management practices of CHD-PAH in central China.

Detailed Description
-----------------
baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart. Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases. Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests main outcome measure include: death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of >15% from baseline in 6MWD (or >30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Official Title
-----------------
Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Other: standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Clinical diagnosis of CHD-PAH (by RHC) Exclusion Criteria: PAH due to other criteria; unable to participate

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: standard of care|No intervention, this a patient registry and is purely an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | To recruit a cohort of CHD-PAH cases. define the death as the primary outcome | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical worsening | number of patients were dead, or having heart/lung transplantation, atrial septostomy, hospitalization due to worsening of PAH, starting of new specific PAH treatment, persistent decrease of >15% from baseline in 6MWD (or >30% compared with last study-related measurement), persistent worsening of WHO FC | 5 years |
Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study

Study Overview
=================
Brief Summary
-----------------
Reprieve Cardiovascular System for the Treatment of Subjects with Acute Decompensated Heart Failure Mechanistic Study

Official Title
-----------------
Reprieve Cardiovascular System for the Treatment of Subjects With Acute Decompensated Heart Failure Mechanistic Study

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

Intervention / Treatment
-----------------
* Other: Fluid Management
* Device: Reprieve Cardiovascular System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized with a diagnosis of heart failure Patients ≥ 18 years of age able to provide informed consent and comply with study procedures. Exclusion Criteria: Inability to place Foley catheter or IV catheter Hemodynamic instability Dyspnea due primarily to non-cardiac causes Acute infection with evidence of systemic involvement Inability to follow instructions or comply with follow-up procedures. Other concomitant disease or condition that investigator deems unsuitable for the study Enrollment in another interventional trial during the index hospitalization Life expectancy less than 3 months

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: Reprieve Cardiovascular System<br> | Device: Reprieve Cardiovascular System<br>* System with Fluid Management Module<br>|
| Active Comparator: Standard of Care<br> | Other: Fluid Management<br>* Removal of excess extracellular fluid using diuretics<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional Excretion of Sodium measured during therapy | Average fractional excretion of sodium across all patients measured during therapy | End of treatment, an average of 24 hours | 
| Device and Procedure related AEs and SAEs | Rate of device and procedure related AEs and SAEs | Through study completion, an average of 90 days |
Investigation of Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Detailed Description
-----------------
For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Official Title
-----------------
A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy

Conditions
-----------------
Pancreaticoduodenectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had underwent pancreaticoduodenectomy between 2008 to 2018. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pancreaticoduodenectomy<br>patients underwent pancreaticoduodenectomy in recent ten years. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Postoperative Pancreatic Fistula(POPF) | The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria. | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | The incidence of operative complications within 90 days after surgery | Within 90 days after surgery | 
| Mortality | The death occurred within 30 days after surgery | Within 30 days after surgery | 
| Duration of operation | The time of operation count by minute. | Intraoperative | 
| Length of hospital stay after surgery | Days between surgery and hospital discharge | From first day after surgery to release from hospital (anticipate 5 days minimally) | 
| Hospital costs | The total hospitalization expenses | From first day after surgery to release from hospital (anticipate 5 days minimally) |
Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)

Study Overview
=================
Brief Summary
-----------------
Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits. In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.

Official Title
-----------------
Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic

Conditions
-----------------
Iron Deposition, Dialysis, Iatrogenic Hemosiderosis

Intervention / Treatment
-----------------
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, female, over 18 years old Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study Exclusion Criteria: Patient who has signed a form to object to the use of their health data Pregnant woman Poor adherence to the dialytic technique Severe cognitive impairment Hepatic cirrhosis Frank inflammatory syndrome or an active infectious disease Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases Recent major bleeding (< 3 months) Recent major surgery (< 3 months) Transfusion dependence Progressive malignant disease Pacemakers incompatible with an MRI and metal heart valves

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 |
| --- | --- |
| Dialysed patients with suspicion of hepatic iron<br>Patients on dialysis at Claude Galien Private Hospital who had one or more MRI scans to monitor possible hepatic iron overload between May 2012 and March 2018. | Procedure: MRI<br>* Pancreatic MRI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of pancreatic iron deposit | Presence of pancreatic iron deposits as a function of hepatic iron level during iron overload in the dialysis patient will be evaluated from the pancreatic iron concentration measured by MRI and expressed by a T2* value in ms. | 1 day |
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.

Official Title
-----------------
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Darifenacin
* Drug: Oxybutynin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 60 and over United States English as a primary language Given written informed consent by signing and dating an informed consent form prior to study entry Exclusion Criteria: Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator Other protocol defined inclusion/exclusion criteria may apply. - Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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 |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily<br>* Other names: Enablex;|
| Active Comparator: 2<br>Oxybutynin | Drug: Oxybutynin<br>* Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Placebo once daily tablet (sham titration)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2. |  |  | 
| Effects on other cognitive domains measured by various tests at week 1,2 and 3. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Darifenacin, oxybutynin, cognition, memory
Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

Study Overview
=================
Brief Summary
-----------------
Our study aims to clarify the impact of the use of a standard sunbed according to new EU guideline EN 60335-2-27 and possibly discount the positive effects of tanning beds. We plan to investigate the serum elevation of 25(OH)D under sunbed use, respecting the new recommendations for the exposure plan for different skin types according to EN 60335-2-27. The use of a sunbed will be compared to a control group not using a sunbed in the observation period. Trial with medical device

Detailed Description
-----------------
We will compare to baseline changes in serum vitamin D and health-related quality of life using a control group and an intervention group.

Official Title
-----------------
Serum 25-OH Vitamin D Modulation by Sunbed Use According to EU Guideline EN 60335-2-27

Conditions
-----------------
Skin Toxicity

Intervention / Treatment
-----------------
* Device: sunbed exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Probands intending to use a commercial sunbed : Age 18 years or older Regular use of commercial sunbeds Oral and written informed consent Exclusion criteria: 1. Skin type I according to Fitzpatrick according to EU guideline EN 60335-2-27 2. Sunbed use within the last three months 3. Use of vitamin D supplements or multivitamin supplements 4. Any medical condition which renders them unfit for sunbed use in the judgment of the investigator 5. Inability to provide oral and written consent to participate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunbed<br>sunbed exposure | Device: sunbed exposure<br>* exposure to sunbed ultraviolet radiation<br>|
| No Intervention: Observation<br>only observation of subjects recruited after randomization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of number of patients with a relevant elevation of serum 25-hydroxyvitamin D levels of =10ug/L from the baseline |  | six months |
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).

Official Title
-----------------
Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B

Conditions
-----------------
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX Treated with room temperature stable NovoSeven®
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: activated recombinant human factor VII<br>* Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory |  | after 25 exposure days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events reported as potentially related to activated recombinant human factor VII |  | after 25 exposure days |