linjc16/ctgov huggingface dataset:
Investigation on Appropriate Duration of Dabigatran Use After Catheter Ablation for Paroxysmal Atrial Fibrillation in Patients With Low Thromboembolic Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. According to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. However bleeding risk with anticoagulant is also problematic. Post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. Also, the risk of thromboembolism is low in patients with CHA2DS2-VASc score less than 1. The investigators hypothesized that dabigatran use for the first 1 month after the RFCA for patients with paroxysmal AF and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.

Conditions
-----------------
Atrial Fibrillation, Thromboembolism

Intervention / Treatment
-----------------
* Drug: dabigatran
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paroxysmal AF undergoing catheter ablation CHA2DS2-VASc score <= 1 informed consent Exclusion Criteria: persistent AF CHA2DS2-VASc score > 2 prior CVA prior atnicoagulant severe HF abnormal liver or renal function history of severe bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short Group<br>The patients taking dabigatran for 1 month after the radiofrequent catheter ablation for paroxysmal atrial fibrillation. | Drug: dabigatran<br> <br> |
| Placebo Comparator: Conventional Group<br>The patients taking dabigatran for 2 months after the radiofrequent catheter ablation for paroxysmal atrial fibrillation. | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of thromboembolic events |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dabigatran
Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.

Official Title
-----------------
Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: paclitaxel plus trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed metastatic breast cancer overexpressing HER2 pretreatment with anthracycline in either the adjuvant or palliative setting. HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+. informed consent Exclusion Criteria: more than 1 chemotherapy for advanced disease taxane or trastuzumab pretreatment brain metastases Eastern Cooperative Oncology Group (ECOG) performance status >1 pregnancy or lactation, childbearing potential without reliable contraception clinically significant cardiac disease, neutrophils <1500/µl, platelets <75,000/µl total bilirubin and creatinine >1.5 × the upper limit of normal

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paclitaxel/trastuzumab<br>Single experimental arm in a phase II trial | Drug: paclitaxel plus trastuzumab<br>* Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Patient follow-up on average for 15 months and up to a maximum of 51 months |
Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose

Study Overview
=================
Brief Summary
-----------------
Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile dysfunction

Official Title
-----------------
Multicenter Randomized Double-Blind, Placebo-Controlled, Fixed-Dose Parallel Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose - II

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: Viagra (Sildenafil Citrate) 100 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men 18-70 years of age Documented clinical diagnosis of erectile dysfunction of at least 3 months duration. Exclusion Criteria: Subjects with penile implants Subjects with a known history of retinitis pigmentosa. Subjects, due to the requirement of 100 mg dosage, who are receiving concomitant treatment with the potent CYP3A4 inhibitor ritonavir.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Viagra (Sildenafil Citrate) 100 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of sexual intercourses that are successful in men with mild to moderate ED 8 hrs after a dose of Viagra. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion (as above) of patients at various endpoints. Other questionnaires such as SEP, IIEF. |  |  |
Quality of Perioperative Invasive Ventilation in PICU

Study Overview
=================
Brief Summary
-----------------
This is purely observational study in which quality of invasive ventilation is observed with electrical impedance tomography (EIT) during perioperative intensive care. EIT parameters will be used to assess if protective ventilation strategies are successfully followed during routine care.

Detailed Description
-----------------
20 neonates and infants undergoing elective surgery and requiring postoperative treatment and follow up in PICU or in pediatric anestesiology clinic, will be included in this prospective observational study. Swisstom BB2-monitor and NeoSensorBelts will be used to monitor their ventilatory care from arrival to the operation room (prior intubation) to postoperative intensive care (until 2 hours after extubation). EIT parameters assessing lung aeration and ventilation distribution will be used to assess the quality of invasive ventilation.

Official Title
-----------------
Electrical Impedance Tomography (EIT) in Assessing the Quality of Perioperative Invasive Ventilation in PICU

Conditions
-----------------
Invasive Ventilation, Elective Surgery

Intervention / Treatment
-----------------
* Device: Swisstom BB2 EIT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent from a parent of legal guardian Infant undergoing elective or semi-elective surgery Postoperative admission to PICU expected Spontaneous breathing prior to study inclusion Exclusion Criteria: Need for respiratory support prior to surgery Thoracic surgery Body weight < 1500g or > 10 kg

Ages Eligible for Study
-----------------
Minimum Age: 2 Hours
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Swisstom BB2 EIT device|Swisstom BB2 EIT device and NeoSensor Belts will be used to assess lung aeration, ventilation distribution and strech during invasive ventilation in perioperative care.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silent spacies | Amount of silent spaces observed in different phases of treatment in comparison to baseline | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation distribution | Changes from baseline in ventilation distribution will be assessed in different phases of treatment | 24 hours | 
| Effect of interventions on ventilatory parameters | Relationship between intubation/invasive ventilation/extubation/spontaneous breathing and EIT findings | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrical impedance tomography
Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Study Overview
=================
Brief Summary
-----------------
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Official Title
-----------------
A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypogonadal males between 18-70 years old with qualifying general medical health Exclusion Criteria: Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  |
An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with Duchenne muscular dystrophy (DMD).

Official Title
-----------------
Long-term, Open-label Extension Study for Patients With Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: Casimersen
* Drug: Golodirsen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed a clinical trial evaluating casimersen or golodirsen, per protocol. Is between 7 and 23 years of age, inclusive, at enrollment. Other inclusion/exclusion criteria apply.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 23 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Casimersen<br>Patients amenable to exon 45 skipping who have completed a clinical trial evaluating casimersen will receive open-label casimersen intravenous (IV) infusions, weekly, at 30 mg/kg for up to 144 Weeks. | Drug: Casimersen<br>* Casimersen solution for IV infusion<br>* Other names: AMONDYS 45;|
| Experimental: Golodirsen<br>Patients amenable to exon 53 skipping who have completed a clinical trial evaluating golodirsen will receive open-label golodirsen intravenous (IV) infusions, weekly, at 30 mg/kg for up to 144 Weeks. | Drug: Golodirsen<br>* Golodirsen solution for IV infusion<br>* Other names: VYONDYS 53;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Serious Adverse Events (SAEs) |  | Up to 30 days after the last infusion of study drug (assessed up to 148 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMD, Duchenne muscular dystrophy, Exon Skipping, Exon 53, Exon 45, Duchenne
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.

Study Overview
=================
Brief Summary
-----------------
To investigate the performance of currently available THVs in terms of safety and efficacy To evaluate potential predictors of THV embolization or migration (TVEM) To assess the impact of TVEM on prognosis

Official Title
-----------------
Performance of Currently Available traNscaTHEter Aortic Valve Platforms in Inoperable Patients With Pure Aortic regurgitatiON of a Native Valve. The PANTHEON International Project.

Conditions
-----------------
Aortic Regurgitation

Intervention / Treatment
-----------------
* Device: TAVR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe aortic regurgitation prohibitive surgical risk Exclusion Criteria: surgical candidates
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TAVR|TAVR|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality |  | 1 year |
Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

Study Overview
=================
Brief Summary
-----------------
Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies

Official Title
-----------------
Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

Conditions
-----------------
Orthopedic Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who need leg major orthopedic surgery age > 18 years patient who need prophylactic doses of fondaparinux Exclusion Criteria: contra-indication to fondaparinux renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| patients with blood sample<br>Patients with major orthopedic surgery and prophylactic doses of fondaparinux who have 3 blood sample during their hospitalization to measure anti-Xa activity | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine an anti-Xa activity value which is predicted of a haemorrhage risk |  | day 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fondaparinux, orthopedic surgery, patients with major orthopedic surgery
Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The aim of our work is to study the effect of total parenteral nutrition (TPN) cycling in preterm infants on hypercalcuria (excessive calcium excretion in urine). TPN cycling refers to administering the TPN over a portion of the day rather than the whole day. Our hypothesis is that cyclic TPN includes more hypercalcuria in preterm infants as compared to continuous TPN. Objectives: Measure Urinary Calcium(Ca) during the periods of continuous and cyclic TPN. Compare the amount of Ca losses in the urine continuous vs. cyclic TPN

Detailed Description
-----------------
Randomized cross over design, in which babies will receive TPN either continuously or on a cyclic basis for 3 days. The patients will then be crossed over to receive the other way of administration over the following 3 days, thus each patient will serve as his or her own control. Continuous TPN will be administered over 24 hours for 3 days, while the cyclic TPN will be given for 18 hours then followed by a Dextrose only solution at the same concentration and rate as the TPN for 6 hours. Trophic feeds up to 20 ml/kg/day will be allowed throughout the study period at the discretion of the attending neonatologist.

Official Title
-----------------
Calciuric Effect and Cyclic Parenteral Nutrition in Preterm Infants

Conditions
-----------------
Preterm Infants, Metabolic Bone Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm babies with birth weights of 1500 gm or less. Expected to be restricted from oral feeding or on trophic feeds On TPN for at least 6 days Exclusion Criteria: Infants who at the time of enrollment are on any diuretics (Lasix, hydrochlorothiazide, Aldactone, etc.) or caffeine those who are hemodynamically unstable Or have renal or hepatic insufficiency Infants with major congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 9 Months

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

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

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
-----------------
Preterm Infant, Parenteral nutrition cycling, TPN cycling, Hypercalcuria
Mechanical Ventilation During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The study is about a protocol of protective mechanical ventilation during cardiopulmonary bypass used during cardiosurgery for the correction of congenital heart diseases, to evaluate what's the best for the lungs

Official Title
-----------------
Evaluation of a Protocol of Protective Mechanical Ventilation During Cardiopulmonary Bypass in Cardiosurgery for Congenital Heart Diseseas

Conditions
-----------------
Mechanical Ventilation Complication, Cardiopulmonary Bypass, Congenital Heart Disease

Intervention / Treatment
-----------------
* Procedure: Ventilation during cardiopulmonary bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital heart diseases younger than 5 years CPB longer than 30 minutes in hypotermia elective surgery stable clinical conditions Exclusion Criteria: genetic anomalies mechanical ventilation before the surgery kidney injuries hepatic failure

Ages Eligible for Study
-----------------
Maximum Age: 5 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ventilated Group<br>This group will receive a protective mechanical ventilation during cardiopulmonary byass. No drugs will be administered. | Procedure: Ventilation during cardiopulmonary bypass<br>* Mechanical ventilation during cardiopulmonary bypass<br>|
| No Intervention: Not-ventilated group<br>This group will not receive any kind of mechanical ventilation during cardiopulmonary byass. The ventilator will be switched off. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the damage of the air-blood membrane in a ventilation protocol and a non ventilation protocol during cardiopulmonary bypass | It will be assed the plasma level of proteins which usually are absent in the plasma (surfactant protein A and B) that change as a damage of the air-blood membrane appears. | Baseline, and 6, 12, 24 and 48 hours after the surgery |