linjc16/ctgov huggingface dataset:
A Prospective Study of Clinical Outcomes for the Pathwork Tissue of Origin Test

Study Overview
=================
Brief Summary
-----------------
The study prospectively assesses the change in cancer-specific clinical decisions and outcomes before and after physicians received results from the Pathwork® Tissue of Origin (TOO) Test for patients whose primary site of cancer origin is uncertain.

Official Title
-----------------
A Prospective Study of Clinical Outcomes for the Pathwork® Tissue of Origin Test

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Device: Pathwork® Tissue of Origin Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: their physician ordered or intends to order a Pathwork® TOO Test between May 2012 and December 2013 the patient is ≥ 18 years of age the patient has given informed consent (online or verbal) the patient is able to understand English.

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 |
| --- | --- |
| Cancer of uncertain primary<br> | Device: Pathwork® Tissue of Origin Test<br> <br> * Other names: Gene expression profile tissue of origin test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neoplasms, Neoplasm Metastasis, Neoplastic Processes, Pathologic Processes
A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine patient variables, physician presenter variables, and information variables that might affect clinical decision making in asymptomatic carotid stenosis. The hypothesis is that information variables are the most significant determinant of clinical decision making.

Official Title
-----------------
A Randomized Trial of Clinical Decision Making in Asymptomatic Carotid Stenosis

Conditions
-----------------
Carotid Stenosis

Intervention / Treatment
-----------------
* Other: One of 6 video presentation by one of 4 presenters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No known history of carotid stenosis Exclusion Criteria: History of dementia Unable to read English

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Video presentation<br> | Other: One of 6 video presentation by one of 4 presenters<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision regarding surgery | Subjects are asked to make a choice regarding surgery after watching a 30 second video. | Approximately 2 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical decision making, Asymptomatic Carotid Stenosis
The Effects of Selective Site Right Ventricular Pacing

Study Overview
=================
Brief Summary
-----------------
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing. When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. What the investigators do not know is why this is the case. Much effort has been directed at looking at features within the left ventricle (LV) for markers of disease progression but little has been investigated regarding the RV. There may be some benefit to pacing the heart preferentially from different parts of the RV and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the RV.

Detailed Description
-----------------
Inclusion Criteria; Patients undergoing elective Electrophysiological Studies +/Ablation Age 18-80 Normal Heart on Pre-procedural Echocardiogram Exclusion criteria; Atrial Fibrillation Evidence of anterograde conducting accessory pathway Permanent Pacemaker insitu Pregnant Breast Feeding Outcome Measures; Change in load-independent indices of LV and RV contractility before and after pacing intervention. LV and RV function measured by transthoracic echocardiography and tissue Doppler imaging.

Official Title
-----------------
Does a Surrogate Marker Exist That Can be Used as A Predictor For Left Ventricular Dysfunction In Patients Undergoing Right Ventricular Pacing

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective Electrophysiological Studies +/Ablation Age 18-80 Normal Heart on Pre-procedural Echocardiogram Exclusion criteria: Atrial Fibrillation Evidence of anterograde conducting accessory pathway Permanent Pacemaker insitu Pregnant Breast Feeding

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supra Ventricular Tachycardia (SVT)<br>Patients undergoing SVT studies | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular Function | Measurement of both right and left ventricular function under differing pacing conditions | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pacing, Haemodynamics, Pilot
JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.

Official Title
-----------------
A Prospective, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer With Previous Chemotherapy Combined With PD-L1 Failure

Conditions
-----------------
Small-cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: JS201 combine with Lenvatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. The imaging diagnosis is the extensive stage of SCLC 2. The patient failed first-line EC+PD-L1 treatment 3 PS 0-1 Exclusion Criteria: 1. Diagnosed as non-small cell lung cancer 2. Women during pregnancy 3. Patients with symptomatic brain metastases 4. PS≥2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Arm A<br>Treatment arm | Drug: JS201 combine with Lenvatinib<br>* JS201 300mg i.v Q2wLenvatinib 8mg po. Qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first) | 1 year |
Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.

Official Title
-----------------
An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

Conditions
-----------------
Hormon Receptor Positive Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication Provision of subject informed consent Exclusion Criteria: If participating in any clinical trial, the subject cannot take part in this study.

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

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women with estrogen receptor positive breast cancer already receiving treatment with an aromatase inhibitor (AI) will be enrolled in the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate compliance rate, as assessed by investigator, after 12 months from baseline. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate compliance rate, assessed by investigator, after 6 months of follow up |  | 12 months | 
| Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months |  | 12 months | 
| Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months |  | 12 months | 
| Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status |  | 12 months | 
| Primary disease (breast cancer) characteristics: receptor status, disease stage |  | 12 months | 
| Disease management data: treatment/treatment changes |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compliance, HR+ breast cancer, epidemiology
Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation

Study Overview
=================
Brief Summary
-----------------
The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle. For this purpose, one of the most studied measures seems to be the measurement of the Psoas Index. This is a contouring of the psoas muscle, performed on an axial section of a CT scan, at the level of the L4 vertebra, which is then matched to the body surface. However, there is no standardization of measurements and volume acquisitions, and different image processing is also described. A radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.

Official Title
-----------------
Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation

Conditions
-----------------
Ventricular Assist Device

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject ((≥18 years old) Subject who underwent surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018 Subject who has not expressed opposition to the reuse of his or her data for research purposes Exclusion Criteria: Subject having expressed opposition to participate in the study Absence of CT scan available at the time of implantation or CT scans older than one year prior to surgery and those older than 72 hours postoperatively No anthropometric data available Subject under legal protection Subject under guardianship or curatorship

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 |
| --- | --- | --- |
| Impact of sarcopenia, measured by the Psoas Index, on 28-day survival in patients undergoing cardiac assistance surgery |  | Survival at 28 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventricular Assist Device, VAD, Sarcopenia, Psoas Index, Cardiac assistance, Cardiac assistance surgery
Blockade of Vascular Potassium Channels During Human Endotoxemia

Study Overview
=================
Brief Summary
-----------------
Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during experimental human endotoxemia.

Official Title
-----------------
Blockade of Vascular Potassium Channels During Human Endotoxemia

Conditions
-----------------
Endotoxemia

Intervention / Treatment
-----------------
* Drug: endotoxin
* Drug: Potassium channel blockers: TEA, Quinin, Tolbutamide
* Drug: L-NMMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: drug, alcohol, nicotine abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: endotoxin|nan|
|Drug: Potassium channel blockers: TEA, Quinin, Tolbutamide|nan|
|Drug: L-NMMA|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics |  | 24 hrs after LPS administration | 
| Markers of Inflammation |  | 24 hrs after LPS administration | 
| Cytokines |  | 24 hrs after LPS administration | 
| Markers of Renal Injury |  | 24 hrs after LPS administration | 
| Inducible NO synthase expression |  | 24 hrs after LPS administration | 
| NO-metabolites |  | 24 hrs after LPS administration | 
| Mediators of Vascular reactivity |  | 24 hrs after LPS administration | 
| Sensitivity to norepinephrine |  | 24 hrs after LPS administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endotoxemia, vascular potassium channels, cytokine, norepinephrine, regional blood flow,, inflammation,, ion channels,, nitric oxide synthase,, pharmacology.
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC). We plan to identify cases of laboratory-proven shigellosis and ETEC-associated diarrhea, to study humoral and cellular immune parameters following natural infections with Shigella and ETEC, and to compare the level of pre-existing local, humoral and cellular immune parameters in cases of shigellosis and ETEC-associated diarrhea and in matched controls.

Conditions
-----------------
Dysentery

Intervention / Treatment
-----------------
* Other: Laboratory Tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lab-confirmed Shigella or ETEC Individuals or patients without diarrheal disease Exclusion Criteria: n/a

Ages Eligible for Study
-----------------
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diarrheal disease<br> | Other: Laboratory Tests<br>* Stool, blood, urine and saliva samples<br>|
| Active Comparator: Control<br>Samples of stool, blood, urine saliva | Other: Laboratory Tests<br>* Stool, blood, urine and saliva samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of cases of shigellosis and ETEC-associated diarrhea | Stool of patients examined in laboratory and identified as infected with the pathogens | Four years |
Nosocomial Bacteriuria in Geriatric Internal Medicine Services and Follow-up Care and Geriatric Rehabilitation of the Strasbourg University Hospitals

Study Overview
=================
Brief Summary
-----------------
This thesis is a comparative study of the epidemiological characteristics of health-care associated bacteriuria in short and medium term of geriatrics wards in Strasbourg's University Hospital, between 2003 and 2017, in the follow-up of Eric de Pasquale's thesis in 2010. This comparative study will allow to see the evolution of urinary bacterial ecology, bacterial sensitivity to antibiotics, and the part of multi-resistant bacteria, during these 14 years in geriatric services in Strasbourg.

Official Title
-----------------
Health Care-associated Bacteriuria in Geriatric Wards in Strasbourg's University Hospital : a Comparative Study of Bacterial Ecology Between 2003, 2007 and 2017

Conditions
-----------------
Urinary Tract Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient of age who has been hospitalized in geriatric wards (rehabilitation car service and internal medicine) of Strasbourg's University hospital date of hospital leaving after 1/1/17 and before 1/1/18 patient who has a health-care urinary tract infection (occurred more than 48h after admission) single bacteria in the CBEU bacteriuria > 105 cfu/mL regardless which clinical context or bacteria if a patient has several bacteriuria, they can be included if they appear after a precedent episode well treated or if the bacteria is different from the precedent Exclusion Criteria: participation refusal Leaving of hospital out of the inclusion period Urinary tract infection which occurred less than 48h after admission (communitarian infection) bacteriuria < 105 cfu/mL multiple bacteria in the CBEU

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 |
| --- | --- | --- |
| Bacterial sensitivity (antibiotic resistance testing) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health care associated urinary tract infection, Bacteriuria, Elderly, Geriatrics, Antimicrobial resistance, Multi-resistant bacteria
PEL-1235_REN-0176-I (Pelicon)

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to investigate whether in patients following kidney transplantation (>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.

Official Title
-----------------
A Multicentre, Prospective, Non-Interventional Study to Assess the Intra-patient Variability of Tacrolimus Once and Twice Daily After Kidney Transplantation

Conditions
-----------------
Immunosuppression After Kidney Transplantation

Intervention / Treatment
-----------------
* Other: tacrolimus Advagraf
* Other: tacrolimus Prograf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed written informed consent male or female patient ≥ 18years of age Patient has received a kidney transplantation at least 6 months prior to inclusion into the study No acute rejection episodes for at least 3 months PRG through level and dosing stable for at least 1 month Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study Exclusion Criteria: Acute rejection episodes within the last 3 months prior to study entry Unstable PRG trough level or dose change in the month before study entry History of noncompliance to medical regimens Patients unwilling to or unable to comply with the protocol Treatment with another investigational product during this study or during the last 30 days prior to study start

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 |
| --- |
|Other: tacrolimus Advagraf|intake of Advagraf once daily for 3 months|
|Other: tacrolimus Prograf|intake of Prograf twice daily for 3 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrapatient variability of tacrolimus through level |  | pre-dose, 1 h post dose and 3 h post dose for 3 month |