linjc16/ctgov huggingface dataset:
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety profile and efficacy of whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) in patients with brain metastases (BM).Patients with BM were randomly assigned to 30 Gy of WBRT with or without concomitant TMZ (75 mg/m2/d) plus two cycles of TMZ (200 mg/m2/d for 5 days).

Official Title
-----------------
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain Metastases: A Randomized Trial

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: Temozolomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically diagnosed as NSCLC, stage IVb [ (American Joint of Cancer Committee(AJCC), 2002) ], Brain metastasis no history of hypertension or diabetes. Exclusion Criteria: the brain tumor diameter >5cm; RPA class =3; pregnancy.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WBRT plus TMZ arm<br>whole brain radiotherapy (WBRT) concomitantly with temozolomide (TMZ) | Drug: Temozolomide<br> <br> |
| No Intervention: WBRT<br>whole brain radiotherapy (WBRT) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 1 month post procedure | 
| Time to central nervous system progress which was confirmed by MRI |  | 1 to 24 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quality of Life |  | 0 to 24 months post procedure | 
| Overall Survival |  | 1 to 24 months post procedure | 
| Toxicity as measured by CTCAE V4.0 |  | 0 to 24 months post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, Radiotherpy, Temozolomide
Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY. The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.

Official Title
-----------------
Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Procedure: Endovascular Repair of the abdominal aorta
* Device: Cook Zenith Stent-Graft
* Device: Talent Stent-Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject with abdominal aortic aneurysm, with or without iliac involvement iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories Exclusion Criteria: less than 18 years of age pregnant or lactating have contraindications for use of contrast medium or anticoagulation drugs are patients who have a condition that threatens to infect the graft are patients with sensitivities or allergies to the device materials

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talent Stent-Graft<br> | Procedure: Endovascular Repair of the abdominal aorta<br>* Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft. EVAR, CTA imaging, 1, 6 12 months post treatment.<br>Device: Talent Stent-Graft<br>* Talent AAA Abdominal Stent Graft System<br>|
| Experimental: Cook Zenith Stent-Graft<br> | Procedure: Endovascular Repair of the abdominal aorta<br>* Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft. EVAR, CTA imaging, 1, 6 12 months post treatment.<br>Device: Cook Zenith Stent-Graft<br>* Cook Zenith AAA Endovascular Graft<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute technical success, successful exclusion of the aneurysm |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients will be matched based on AAA neck length and neck and iliac angulation
The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
To examine the effects of the addition of clonidine to diuretics on the mobilization of ascites at short-term (diuretic response and requirement of diuretics) and long-term (readmissions for tense ascites and requirement of diuretics) in cirrhotics with increased sympathetic nervous system. Secondary objectives were to study neuro-hormonal,hemodynamic effects and side effects of clonidine and diuretics.

Official Title
-----------------
The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients With Ascites and Activation of Sympathetic Nervous System: a Randomized Double-Blind Placebo Controlled Study.

Conditions
-----------------
Ascitic Cirrhosis, Hyperactivation of Sympathetic Nervous System

Intervention / Treatment
-----------------
* Drug: clonidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhotic patients with ascites Plasma norepinephrine level > 300 pg/mL (normal value: 185 - 275 pg/mL) Exclusion Criteria: Serum bilirubin concentration above 4.5 mg/dL Prothrombin time below 40% Platelet count below 40 X 10¨9/liter Serum creatinine concentration above 2 mg/dL Gastro-intestinal hemorrhage Alcoholic hepatitis Diabetes mellitus, Hepatocellular carcinoma Respiratory or cardiac failures Hepatic encephalopathy Bacterial infection

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: Factorial Assignment
Masking: Double


Arms and Interventions

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

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
-----------------
renin, norepinephrine, aldosterone, hemodynamics, spironolactone
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.

Official Title
-----------------
A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure

Conditions
-----------------
The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Disease-Management intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure ( I50) during the last 12 months Heart failure grade NYHA II- III Accurate heart failure diagnosis Living in one of four Swedish counties where the trial is ongoing Exclusion Criteria: Deceased In a moribund state Significant cognitive loss and therefore cannot provide consent Psychosis diagnosis Severe hearing impairment Language difficulties Participants in another study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease-Management intervention<br>Behavioral: Disease-Management intervention The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person | Behavioral: Disease-Management intervention<br>* The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person<br>|
| No Intervention: No Intervention: Control arm<br>Control group not receiving any in | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospitalizations |  | From randomization for up to 2 years | 
| Number of outpatient visits to medical doctor |  | From randomization for up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | From randomization for up to 2 years | 
| Length of hospital stays |  | From randomization for up to 2 years | 
| Total health care cost |  | From randomization for up to 2 years |
Optimal Catheter Placement During Sonohysterography: Comparison of Cervical to Uterine Placement

Study Overview
=================
Brief Summary
-----------------
The primary objective of this investigation was to evaluate if the location of placement of the SIS balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.

Detailed Description
-----------------
The use of sonography combined with intrauterine saline instillation, termed sonohysterography

Official Title
-----------------
Optimal Catheter Placement During Sonohysterography: A Randomized Clinical Trial Comparing Cervical to Uterine Placement

Conditions
-----------------
Catheter Placement and Perceived Pain

Intervention / Treatment
-----------------
* Procedure: cervical vs. uterine placement of balloon catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients undergoing SIS for diagnostic uterine cavity evaluation at our university's Reproductive Endocrine Infertility Program. Exclusion Criteria: previous hysterectomy, current pregnancy, active PID, patulous or stenotic cervical os noted on previous history or physical exam.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cervical vs. uterine placement of balloon catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: perceived discomfort |  | during sonohysterography procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure: Time required to perform procedure; Measure: Volume of media required to perform procedure |  | during sonohysterography procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sonohysterography, catheter placement
Physicians Work Distribution in a Danish Emergency Department

Study Overview
=================
Brief Summary
-----------------
physicians in the Emergency Department spend their time on interviewing and examining patients, file documentation, communication with colleagues about the patients. Introduction of IT technology aims to reduce the administrative workload. However it is the impression that more and more time are used behind the PC rather than at the side of the patient. The aim of this study is to describe how the time is distributed between different task for an ED physician, and to analyse whether there are differences in time distribution if the physician is working in the outpatient area versus admission area of the ED.

Conditions
-----------------
Time Usage of ED Physicians

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ED physicians employed in the ED department Exclusion Criteria: -
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 |
| --- | --- | --- |
| time in minutes used by Emergency Department (ED) physician on direct patient contact, documentation, communication about the patient. | the time measured in minutes used by the emergency physician on direct patient contact, examination and treatment, documentation in IT systems and communication with other health staff about the patient is counted by indepedent observer | first 24 hours after patient arrival to ED |
Postoperative Results of Surgical Treatment of Lung Cancer After 30 Days

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, descriptive analysis of (1) 30 day postoperative results of surgery for lung cancer, (2) 30 day outcome predictors - compared to an earlier similar study in the same hospital (St Olav University Hospital, Trondheim, Norway).

Official Title
-----------------
Postoperative Results of Surgical Treatment of Lung Cancer After 30 Days

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung cancer patients after surgery in 2002-2004 at dept for Heart and Lung Surgery, St.Olavs University Hospital, Trondheim, Norway. Exclusion Criteria: Carcinoid tumor, small-cell lung cancer, lung metastases
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 |
| --- | --- | --- |
Biological Biomarkers in MOMS Partnership

Study Overview
=================
Brief Summary
-----------------
The investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers and children within the New Haven MOMS Partnership, a well-established community-partnered research setting. The proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.

Official Title
-----------------
Biological Biomarkers in MOMS Partnership

Conditions
-----------------
Psychological Stress

Intervention / Treatment
-----------------
* Other: Biological Sample Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking adult mothers (age 21 or older) of at least one biological child mothers must be able to answer three verification questions to confirm they are the biological parent of their child Exclusion Criteria: Non-english speakers Women not able to provide informed consent and with no biological children Mothers under the age of 21

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Biological Sample Collection|Anthropomorphic biomarkers including height, weight, heart rate, and blood pressure will be taken for each participating mother and child by a research assistant trained to accurately perform these procedures. Blood spots will be collected in finger stick proficiency, using trigger activated lancets to administer finger sticks. Each participating mothers and child will provide a saliva sample using Oragene DNA saliva collection kits|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Mother-Child Dyads Who Complete Assessments & Biological Samples | Feasibility outcome | End of study (approximately 5 years) | 
| Telomere Length | Telomere length will be measured using an adapted method of the Cawthon Telomere Assay | At baseline-After 90 minutes | 
| Advanced Glycation End Products (AGEs) | AGEs or (advanced glycation endproducts) will be measured using a painless non- invasive retinal scanning device that measures autofluorescence of the crystalline lens of the eye | At baseline-After 90 minutes |
Effect of Mindful Eating on Body Mass Index in Obese Adolescents

Study Overview
=================
Brief Summary
-----------------
This study is designed to study the effect of a family based mindfulness training program with special focus on diet and nutrition on weight and cardiovascular risk markers in obese adolescents.

Detailed Description
-----------------
40 obese adolescents would be randomized into either a mindfulness based behavioral modification program or standard dietary counseling. At least one parent would be expected to attend the counseling sessions. Patients would be followed for a period of 6 months. Anthropometric parameters, questionaiires relating to quality of life and blood tests would be drawn at baseline and and at 6 months.

Official Title
-----------------
Effect of Mindful Eating on Body Mass Index and Cardiovascular Risk Markers in Obese Adolescents: A Pilot Randomized Clinical Trial

Conditions
-----------------
Adolescent Obesity

Intervention / Treatment
-----------------
* Behavioral: Mindful Eating
* Behavioral: Standard dietary counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria BMI at or greater than the 95th percentile for age and gender Exclusion Criteria

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Eating<br>Subjects and at least one of their parents will receive mindful eating based behavioral modification program | Behavioral: Mindful Eating<br>* Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions<br>|
| Active Comparator: Standard Dietary Couseling<br>Subjects and their parents will receive standard nutritional counseling provided by a registered dietician | Behavioral: Standard dietary counselling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Body Mass Index would be calculated at baseline, at 3 months and at 6 months | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Well validated questionnaires of quality of life would be assessed at baseline, at 3 months and at 6 months. | Baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Adolescence, Mindful Eating