linjc16/ctgov huggingface dataset:
Complete Clinical Responders to Definite Chemoradiation in Esophageal Cancer : a Survival Analysis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify prognostic factors for outcome in patients being complete clinical responders with chemoradiation or radiation for esophageal cancer

Official Title
-----------------
Predictors of Survival for Complete Clinical Responders to Definite Chemoradiation or Radiation Therapy for Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: Chemotherapy
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: localized or locally advanced esophageal cancer patient who underwent definite chemoradiation or radiation patient with complete clinical response Exclusion Criteria: metastatic disease

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: Chemotherapy|Chemotherapy according to standard|
|Radiation: Radiotherapy|Radiotherapy according to local standard|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of prognostic factors for overall survival | Correlation between survival and baseline,clinical and treatment characteristics | From date of treatment until death, assessed up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of treatment failure | Type of recurrence : local, regional, distant. | From date of treatment until treatment failure, assessed up to 10 years | 
| Disease-free survival | Time between the end of treatment and the occurence of progression | From date of treatment until progression or death, assessed up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer, radiochemotherapy, prognosis
Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability

Official Title
-----------------
Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's disease patients<br> | Drug: Pramipexole<br> <br> * Other names: Sifrol®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cumulative daily doses of Sifrol® | Changes in the doses between visits are evaluated using Wilcoxon's signed rank test | up to 8 weeks | 
| Changes in cumulative daily doses of L-dopa | Changes in the doses between visits are evaluated using Wilcoxon's signed rank test | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score |  | Baseline, after 8 weeks | 
| Change from Baseline in SPES subscales | Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy | Baseline, after 8 weeks | 
| Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score | patients with SPES depression >= 2 | Baseline, after 8 weeks | 
| Change from Baseline in Tremor Impact Scale (TIS-D) total score |  | Baseline, after 8 weeks | 
| Change from Baseline in global Parkinson's Disease (PD) symptoms | Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor | Baseline, after 8 weeks | 
| Global assessment of efficacy by investigator on a 5-point scale |  | after 8 weeks | 
| Global assessment of tolerability by investigator on a 5-point scale |  | after 8 weeks | 
| Number of patients with adverse events |  | up to 8 weeks | 
| Number of patients with adverse drug reactions |  | up to 8 weeks |
Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.

Official Title
-----------------
Extended Access Program and Retrospective Chart Review for Lorcaserin in Dravet Syndrome and Other Refractory Epilepsies

Conditions
-----------------
Epilepsies, Myoclonic, Drug Resistant Epilepsy

Intervention / Treatment
-----------------
* Drug: Lorcaserin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Dravet syndrome (according to Recommendation from a North American Consensus Panel, 2017) or other refractory epilepsy (per the judgment of the treating physician) Male or female, age at least 2 years at the time of informed consent Currently treated with lorcaserin, that the treatment is for Dravet syndrome or other refractory epilepsies, and the treatment was initiated before 13 Feb 2020; or has completed Study E2023-A001-304 Has a clinical benefit from lorcaserin in the opinion of the treating physician Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lorcaserin|Lorcaserin 10 milligram (mg) tablets orally.|

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
-----------------
Extended Access Program, Expanded Access Program, Dravet Syndrome, Refractory Epilepsies, Lorcaserin
Complications Following Pacemaker Implantation

Study Overview
=================
Brief Summary
-----------------
This study examines possible risk factors with regard to complications following pacemaker implantation.

Detailed Description
-----------------
This study examines possible risk factors with regard to complications following pacemaker implantation. We are using data from The Danish Pacemaker Register.

Official Title
-----------------
Complications Following Pacemaker or ICD Implantation: Results From The Danish Pacemaker and ICD Register

Conditions
-----------------
Bradycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: permanent cardiac pacemaker 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 |
| --- | --- |
| pacemaker group<br> | |

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
-----------------
pacemaker, adverse effects
Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)

Study Overview
=================
Brief Summary
-----------------
compare the prone with the prone-flexed position accessibility of upper and middle calyceal approach by subcostal puncture and PCNL reporting complications using the Clavien-Dindo system with Categorisation of PCNL-specific complications according to Clavien-Dindo classification score

Official Title
-----------------
Prone Versus Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) Comparing Efficacy and Complication According to Clavien-Dindo Classification Score Randomised Controlled Study

Conditions
-----------------
Prone-Flexed Position, Complication of Surgical Procedure, Percutaneous Nephrolithotomy (PCNL), Prone Position

Intervention / Treatment
-----------------
* Procedure: Prone-Flexed PCNL
* Procedure: Prone PCNL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Large renal pelvic stone Upper calyceal stone Middle calyceal stone Exclusion Criteria: lower calyceal stone Bilateral simultaneous PCNL Need for 3 percutaneous tracts intraoperative Morbid obesity (BMI >40) Non opaque renal stones. Refuse to complete study requirements

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prone-Flexed PCNL<br>Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL) | Procedure: Prone-Flexed PCNL<br>* Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)<br>* Other names: Prone-Flexed Percutaneous Nephrolithotomy;|
| Active Comparator: Prone PCNL<br>Prone Position For Percutaneous Nephrolithotomy (PCNL) | Procedure: Prone PCNL<br>* Prone Position For Percutaneous Nephrolithotomy (PCNL)<br>* Other names: Prone Percutaneous Nephrolithotomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the prone with the prone-flexed position for PCNL reporting complications | Outcome measures by using the clavien dindo classification system | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of stone free rate (SFR) of the two groups | Outcome measures by stone fragment residual ≤ 2 mm by computed tomography (CT) | 1 year | 
| Asses the easiness of accessibility of the targeted stone | Outcome measures by counting number and site of puncture trial | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous Nephrolithotomy (PCNL), Clavien-Dindo Classification Score, Prone-Flexed Position
Whole Exome Sequencing in Bicuspid Aortic Valve Patients

Study Overview
=================
Brief Summary
-----------------
Bicuspid aortic valve (BAV), congenital anomaly present in 2% of the population, is defined by the presence of two sigmoid valves instead of three. It is conventionally associated with histological abnormalities of the wall of the ascending aorta, risk factors of aortic dystrophy observed in 50% of cases, and dissection. Long considered an accident of development, the discovery of mutations in the NOTCH1 gene in 2 families alternating BAV and aortic dystrophy suggests the existence of a genetic predisposition and a common genetic origin for these two pathologies. Data on the genetic basis of the BAV are still limited, but the existence of a large phenotypic diversity suggests the involvement of other genes. The establishment of large collections of DNA will allow great advances in this field. The purpose of this project is to confirm the existence of a genetic determinism at the origin of the BAV with or without dystrophy of non syndromic ascending aorta, identifying genetic defects associated with the presence of a BAV in a series of candidate genes.

Conditions
-----------------
Bicuspid Aortic Valve

Intervention / Treatment
-----------------
* Biological: Extra blood draw samples
* Biological: additional tissue samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography With or without an aneurysm of the ascending thoracic aorta nonsyndromic Exclusion Criteria: aortic syndromic pathology antecedent of acute articular rhumatism

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bicuspid aortic valve (BAV)<br>patient with bicuspid aortic valve | Biological: Extra blood draw samples<br> <br> Biological: additional tissue samples<br> <br> |
| Active Comparator: healthy subjects related patients with BAV<br>healthy control, related to patient with bicuspid aortic valve, at the 1st, 2nd or 3rd degree | Biological: Extra blood draw samples<br> <br> |
| Active Comparator: Tricuspid aortic valve (TAV)<br>patient with aortic stenosis on tricuspid valve | Biological: additional tissue samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of genetic abnormalities |  | 3 years |
The BEACON Registry: Best Expert Agreement for Care of Occult Myocardial Infarction (MI) Nationally

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to assess and improve the process of care and health outcomes of patients presenting to the Emergency Department with chest pain suspected to be of cardiac origin. The study will identify which methods facilitate the diagnosis and risk stratification of ST elevation myocardial infarction (STEMI) or non STEMI, including patients with occult myocardial infarction (MI), and result in a shorter time to definitive diagnosis and treatment.

Detailed Description
-----------------
The BEACON Registry is a multi-center data collection and follow-up registry. Participating Sites will collect information on patients presenting to the Emergency Department (ED) with chest pain. The purpose of the BEACON Registry is to evaluate the impact of new technologies, practice patterns and initiatives on patient time to diagnosis, patient time to treatment, patient survival and overall economics.

Official Title
-----------------
The BEACON Registry: Best Expert Agreement for Care of Occult MI Nationally

Conditions
-----------------
Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with chest pain suspected to be of cardiac origin. Exclusion Criteria: None

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 |
| --- | --- |
| I<br>Patients presenting to the Emergency Department with chest pain suspected to be of cardiac origin. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to definitive diagnosis of STEMI, UA/NSTEMI and non-cardiac chest pain; time to disposition decision will be used as an objective measure of time to definitive diagnosis |  | Index hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment, economic outcomes and survival outcomes |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest Pain, STEMI, UA/NSTEMI, ACS, Emergency Department
A Study to Evaluate the Effect of Danoprevir/Ritonavir on the Pharmacokinetics of Escitalopram and S-Demethylcitalopram in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This single-arm, open-label, non-randomized study will evaluate the effect of danoprevir/ritonavir on the pharmacokinetics of escitalopram and S-demethylcitalopram in healthy volunteers. Healthy volunteers will receive oral doses of danoprevir/ritonavir and escitalopram. The anticipated time of the study is 6 weeks.

Official Title
-----------------
A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) in Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: danoprevir
* Drug: escitalopram
* Drug: ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteers, aged 18 to 55 years, inclusive Body mass index (BMI) 18.0 to 32.0 kg, inclusive Absence of evidence of any active or chronic disease Non-smokers Exclusion Criteria: Presence of any active or chronic disease Abnormal blood pressure Abnormal resting heart rate Abnormal ECG values History of any clinically significant cardiovascular or cerebrovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: danoprevir<br>* oral doses of danoprevir<br>Drug: escitalopram<br>* oral doses of escitalopram<br>Drug: ritonavir<br>* oral doses of ritonavir<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in area under the plasma concentration time curve (AUC) of escitalopram |  | Approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | Approximately 6 weeks | 
| Effect on pharmacokinetics of major escitalopram metabolite: change in AUC of S-demethylcitalopram |  | Approximately 4 weeks | 
| Effect of co-administration of escitalopram on danoprevir/ritonavir steady-state pharmacokinetics: change in AUC of danoprevir/ritonavir |  | Approximately 4 weeks |
Patients With Chemotherapy-induced Polyneuropathy Are Treated With an Integrated Program Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training

Study Overview
=================
Brief Summary
-----------------
In a Phase-III Study Patients With Chemotherapy-induced Polyneuropathy (NCI CTC Grade 2/3) Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises (Standard) or With Whole-body Vibration (WBV) Platform Training (Experimental).

Detailed Description
-----------------
Subjects with a haematological malignancy or solid and a diagnosis of a chemotherapy-induced polyneuropathy. In a phase-III study patients with chemotherapy-induced polyneuropathy (NCI CTC grade 2/3) are randomized for an integrated program (IP) including massage, mobilization in posture and transport layers, physical exercises (standard) or with whole-body vibration (WBV) platform training (experimental). 15 training sessions in a time period of 12 to 15 weeks were intended. Evaluation included locomotor and neurological tests and self-assessment-tools. The primary objective of the study was the physical fitness and coordination assessed by the chair-rising test (CRT).

Official Title
-----------------
Study Patients With Chemotherapy-induced Polyneuropathy Are Randomized for an Integrated Program (IP) Including Massage, Mobilization in Posture and Transport Layers, Physical Exercises or With Whole-body Vibration Platform Training

Conditions
-----------------
Polyneuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 to 70 years of age with solid and hematological neoplasms suffering from chemotherapy-induced polyneuropathy grade II-III according to National Cancer Institute Common Toxicity Criteria (NCI CTC, version 3.0) and pathological chair-rising test (CRT)28 ( ≥10 s) were eligible Exclusion Criteria: psychiatric disorders plasmatic coagulation disorders thrombotic/thromboembolic events within 6 months before randomization severe neurological disorders like seizures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Group A<br>Whole body vibration training manuelle therapy exercises for power and coordination performance training as needed | |
| Group B<br>manuelle therapy Exercises for power and coordination Performance training as needed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The primary endpoint of the study was achievement of normal values (<10 seconds) in the chair-rising test at the last assessment 4 weeks after the last intervention. |  | 12 weeks |