linjc16/ctgov huggingface dataset:
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.

Official Title
-----------------
A Randomized Phase III Trial of Chemotherapy Alone Versus Chemotherapy Followed by Gefitinib in Stage IIIB/IV Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: platinum-based chemotherapy alone (up to six cycles)
* Drug: platinum-based chemotherapy followed by maintenance therapy with gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed NSCLC Stage IIIB/IV No prior treatment Measurable disease ECOG PS 0-1 Adequate organ function Age 20-74 Written informed consent Exclusion Criteria: Pregnancy or breast feeding Past history of drug hypersensitivity SVC syndrome Pleural or pericardial effusion that required drainage Active infection Interstitial pneumonia or active lung fibrosis Symptomatic brain metastasis Active concomitant malignancy Uncontrolled diabetes Uncontrolled heart disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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

| Intervention/Treatment |
| --- |
|Drug: platinum-based chemotherapy alone (up to six cycles)|nan|
|Drug: platinum-based chemotherapy followed by maintenance therapy with gefitinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over all survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  |  |
Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.

Study Overview
=================
Brief Summary
-----------------
Comparison of two asthma treatments by lung function measures.

Official Title
-----------------
Randomised, Double-blind Parallel Group Study to Assess the Bronchodilative and Bronchoprotective Properties of SERETIDE DISKUS ® Inhlaer 50/100mcg Twice Daily vs. FLIXOTIDE® Inhaler 200mcg Twice Daily.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Salmeterol/fluticasone propionate
* Drug: Fluticasone propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Currently receiving 200-800mcg/day beclomethasone dipropionate. sRAW value of 1.3 kPa's. Exclusion Criteria: 3 or more courses of oral steroids in last 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Salmeterol/fluticasone propionate<br> <br> Drug: Fluticasone propionate<br> <br> * Other names: Salmeterol/fluticasone propionate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sRAW (k.Pa.s) measured before the study medication dose at the end of treatment (week 6) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sRAW measured pre-dose at Week 3. sRAW measured 48 hours after last study medication dose. % symptom-free days over Weeks 1-6. % symptom-free nights over Weeks 1-6. Type and frequency of adverse events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, inhaled corticosteroids
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury

Study Overview
=================
Brief Summary
-----------------
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury

Official Title
-----------------
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Lower Chin &Lip Sensation Post Inferior Alveolar Nerve Injury and Ablative Mandibular Resectons

Conditions
-----------------
Injury of Mental Nerve of One Side

Intervention / Treatment
-----------------
* Procedure: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hemimandiblectomy Patients with Injured Inferior Alveolar Nerve which not showing any healing after 9 months Age group : from 15 to 60 years old No sex predilection Patients with no contraindications to surgical intervention Exclusion Criteria: • Patients with systemic condition counteracting with the surgical procedure.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 60 Years

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

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

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 |
| --- | --- |
| Other: patient lost sensation ant half of lower lip<br>patient with injured inferior alveolar nerve at one side | Procedure: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury<br>* -sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury | The primary outcome is restoration of sensation of lower lip and chin sensation determined by Two discrimination point test at 6 months . Aggregation will be done by percentage/ratio of successful cases number in the study. Calculation of the mean of all cases will be performed for analysis of the results. | 1 year |
Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination

Study Overview
=================
Brief Summary
-----------------
Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination

Detailed Description
-----------------
Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA < 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination. The change of PSA will be evaluated.

Official Title
-----------------
Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: Blood test (PSA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males Intact Rectum Prostate Cancer eligible for active surveillance Exclusion Criteria: Pror radiation therapy Under Androgen Deprivation Therapy Prior prostate surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Surveillance<br>Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement | Other: Blood test (PSA)<br>* Measurement of blood PSA levels<br>|
| Active Comparator: Controls<br>Patients without known diagnosis of prostate cancer Intervention - PSA measurement | Other: Blood test (PSA)<br>* Measurement of blood PSA levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of PSA elevation after DRE |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PSA, prostate cancer, digital rectal examination
Assessment of Renal Function in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to help determine whether cystatin C is a more sensitive laboratory measurement for renal function in cirrhotic patients.

Detailed Description
-----------------
Serum cystatin C, creatinine clearance based calculations, and 125I-Iothalamate clearance (Glofil) will be obtained in 220 patients with cirrhosis. Utilizing this information, the correlation between cystatin C and 125I-Iothalamate clearance will be obtained. In addition, the current serum creatinine based calculations and true creatinine clearance will also be correlated with 125I-Iothalamate clearance. The results of this study should help to determine whether serum cystatin C is a more sensitive laboratory measurement of renal function in patients with cirrhosis.

Official Title
-----------------
Assessment of Renal Function in Cirrhotic Patients -A Comparison of Cystatin C and Creatinine Based Calculations to 125I-iothalamate

Conditions
-----------------
Liver Failure, Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 undergoing evaluation for a liver transplant Exclusion Criteria: known allergy or sensitivity to 125I-Iothalamate

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 |
| --- | --- | --- |
| Creatinine based blood and urine laboratory tests as a measure of renal function in patients with chirrosis of the liver. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal function, cirrhotic patients, transplant evaluation
Intensive Communication for Chronically Critically Ill

Study Overview
=================
Brief Summary
-----------------
This study was a trial of a formal system of family meetings to support family decision makers of chronically critically ill patients in the intensive care unit.

Detailed Description
-----------------
Formal family meetings have been recommended as a useful approach to assist in goal setting, facilitate decision making, and reduce use of ineffective resources in the ICU. We implemented an intensive communication system to test the effect of regular, structured formal family meetings on patient outcomes among long-stay ICU patients The design was a pre-post, tandem assignment of patients (n=217) receiving usual care and communication, followed by enrollment of intervention patients (n=354), from 5 ICUs. The intensive communication system included: (1) family meeting within 5 days of ICU admission and weekly thereafter; (2) each meeting addressed medical update, values and preferences, goals of care; treatment plan, and milestones for judging effectiveness of treatment. We measured differences between control and intervention patients in indicators of aggressiveness of care or timing of treatment limitation decisions (ICU mortality, LOS, duration of ventilation, treatment limitation orders, or use of tracheostomy or percutaneous gastrostomy). Difference in outcomes among patients who died or who had treatment limitation orders, comparing control and intervention groups, was also examined.

Official Title
-----------------
Intensive Communication for Chronically Critically Ill

Conditions
-----------------
Critical Care

Intervention / Treatment
-----------------
* Other: Intensive Communication System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cognitively impaired mechanical ventilation >3 days not expected to be discharged before 5 days having a family decision maker Exclusion Criteria: no family member hospice referral

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Communication<br>regular family meeting every 5 days. | Other: Intensive Communication System<br>* Regular family meetings once a week, using a standard protocol<br>* Other names: Intervention arm;|
| No Intervention: Control<br>usual care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay and depression |  | ICU admission, Day 5, discharge, and 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, critical care
Ultrasonographic Evaluation of the Radial and Ulnar Blood Flow After Radial Arterial Cannulation

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized study was to compare the impact of two different radial arterial catheters - 20G and 22G - on the changes of diameter, blood flow and velocity of radial artery and ulnar artery after induction of anesthesia and after cannulation.

Conditions
-----------------
Radial Artery, Regional Blood Flow

Intervention / Treatment
-----------------
* Device: 22 gauge catheter
* Device: 20 gauge catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient who are scheduled for elective surgery and need arterial cannulation Exclusion Criteria: Coronary occlusive disease Known or suspected upper extremity peripheral arterial disease Coagulopathy DM with peripheral neuropathy Infection at puncture site

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| 20 gauge group<br> | Device: 20 gauge catheter<br>* radial artery cannulation using 20 gauge catheter<br>|
| 22 gauge group<br> | Device: 22 gauge catheter<br>* radial artery cannulation using 22 gauge catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial artery diameter and blood flow before and after cannulation |  | 30 min | 
| Ulnar artery diameter and blood flow before and after cannulation |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of radial artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G) |  | 30 min | 
| The differences of ulnar artery diameter and blood flow after cannulation between catheter gauge(20- and 22-G) |  | 30 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial artery, ulnar artery, catheterization, regional blood flow
A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Official Title
-----------------
A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)

Conditions
-----------------
Restless Legs Syndrome (RLS), Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Ropinirole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or creepy-crawly sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms. Patients must give written informed consent prior to any specific study procedures. Exclusion criteria: Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder. Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy. Patients suffering from other movement disorders (i.e. Parkinson's Disease). Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome. Participation in any clinical drug or device trial in the last three months. Other inclusion or exclusion criteria to be evaluated by the physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in RLS severity rating scale at Week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLS, fatigue, sleep, sleep disorder, Legs, Restless Legs Syndrome, Ropinirole
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.

Official Title
-----------------
A Prospective Clinical Evaluation of the TVA FLEX-1 Device Protocol FLEX-1-001

Conditions
-----------------
Chronic Kidney Disease (CKD)

Intervention / Treatment
-----------------
* Device: Endovascular AVF (EndoAVF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for a native surgical arteriovenous fistula, as determined by the treating physician. Adult (age >18 years old). Advanced chronic kidney disease (CKD), stage 4 or 5 electing for hemodialysis. Written informed consent obtained

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular AVF (EndoAVF)<br>The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access. | Device: Endovascular AVF (EndoAVF)<br>* The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.<br>* Other names: FLEX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The safety of the FLEX-1 system based on the overall complication rates derived from adverse event data. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access Functionality | The functionality of the AVF will be measured based on use of the AVF with two needles for at least 75% of dialysis sessions over a 4-week period following at least a one month maturation period. | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, Arteriovenous fistula (AVF), Hemodialysis, Vascular access, Endovascular AVF (EndoAVF)