linjc16/ctgov huggingface dataset:
4D FDG PET in Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
FDG PET-CT image acquisition in the abdominal and thoracic region is influenced by organ motion. Respiratory movement blurs the metabolic signal of the esophageal tumor and lymph nodes. The investigators hypothesize that the metabolic signal obtained with motion compensation results in higher SUV-max values and clearer demarcation of the esophageal tumor and lymph nodes.

Detailed Description
-----------------
Patients will receive a normal 3D FDG PET-CT scan. By participating in this trial, one extra 4D CT scan will be made. For both the PET and the 4D CT acquisition, the patient gets an abdominal belt around the waist to register breathing motion. No extra FDG PET scan is required for this study. The 4D CT scan is the only intervention which increases the radiation dose exposure compared to the standard PET-CT scan. However, in comparison to the expected radiation dose delivered, if a patient will be treated with curative chemoradiotherapy, this increase in radiation dose is negligible and secondary risks due to this intervention are therefore not increased. For patients who are not eligible for curative treatment the extra dose is also not relevant, given the life expectancy of this group.

Official Title
-----------------
4D PET-CT Imaging in Esophageal Cancer

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

Intervention / Treatment
-----------------
* Other: 4d PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathology proven esophageal cancer or tumor highly suspicious for esophageal cancer > 18 years Written informed consent Exclusion Criteria: <18 years Possibility of pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4D PET-CT<br>Other intervention: 4D PET-CT | Other: 4d PET-CT<br>* Patients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The estimation of tumor size of the primary esophageal tumor on 4Dvs 3D FDG PET |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of SUV max, SUV mean, and SUV peak in 4D versus 3D images of esophageal cancer and lymph nodes and number of suspected involved lymph nodes | measurement of the SUV is a composite measurement in each FDG PET scan | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
4D PET-CT
CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing approval, when used in normal clinical practice within the labeled indications.

Official Title
-----------------
CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: CYPHERTM Sirolimus-Eluting Coronary Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cypher stent Exclusion Criteria: N/A
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

| Intervention/Treatment |
| --- |
|Device: CYPHERTM Sirolimus-Eluting Coronary Stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE at 30 days, 6 months and 1 year. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There is no pre-specified secondary outcome. |  |  |
Evaluate the Association Between Infection and Thrombocytopenia

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the association between nosocomial bloodstream infection and the occurrence of thrombocytopenia in surgical critical ill patients.

Official Title
-----------------
Evaluate the Association Between Blood Stream Infection (BSI) and Thrombocytopenia (Surgical Intensive Care Unit)SICU Patients

Conditions
-----------------
Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sequential consenting adult patients of either sex were prospectively enrolled into the study. Exclusion Criteria: Patients who passed away within 24 hours after hospitalization would be excluded. Patients who developed into a bloodstream infection within 48 hours after hospital admission were also excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| BSI group with thrombocytopenia<br>BSI patients with thrombocytopenia | |
| Non-BSI group with thrombocytopenia<br>Non-BSI patients with thrombocytopenia | |
| BSI group without thrombocytopenia<br>BSI patients without thrombocytopenia | |
| Non-BSI group without thrombocytopenia<br>Non-BSI patients without thrombocytopenia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate |  | 28 days |
Tobacco Impact on Quality of Life on Snus-use, Dual Use, Smoke Use and Non-using.

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study was to compare HRQOL in snus-users and dual users (snus and smoking) with never tobacco users. Secondary aim included comparing HRQOL in smokers with non-smokers.

Detailed Description
-----------------
Tobacco use is a major public health issue. The number of smokers decrease simultaneously as oral moist snuff (called snus), is promoted as a healthier alternative in spite its' negative health effects. Studies of health-related quality of life (HRQOL) of those who use snuff are lacking. Recruitment of 674 women and 605 men aged 18 to 65 years through a Swedish population data-base was performed for this cross-sectional study in southwestern Sweden. Subjects completed a questionnaire about tobacco use and the 36-item Short Form Health Survey (SF-36). The non-parametric Mann-Whitney test was used for statistical analysis.

Official Title
-----------------
Tobacco Impact on Quality of Life, a Cross-sectional Study on Snus-use, Dual Use, Smoke Use and Non-using.

Conditions
-----------------
Tobacco Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 years Exclusion Criteria: not understand the Swedish language
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 |
| --- | --- | --- |
| Health-related quality of life was measured using SF-36. | The SF-36 collected data on perceived health status in eight domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH). The physical component summary (PCS) and mental component summary (MCS). Scores range from 0 to 100 with higher scores representing a higher perceived health | The time when the data entry is made, about 8 weeks | 
| Tobacco habits. | The term pack-year (numbers of cigarettes / day * number of years / 20) and box-year (numbers of snuff boxes / week * number of years) was used to describe tobacco use. The variables smoking and snuff use were transformed from one pack-year to pack-decades by dividing pack-year by 10. Similarly, box-years were transformed to box-decades and age from years to decades. | The time when the data entry is made, about 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cigarette smoking, Health, Population characteristics, Quality of life, Tobacco smokeless.
An Analgesia Protocol for Acute Renal Colic in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
An analgesia protocol for acute renal colic will lead to faster significant reductions in pain than prior practice.

Detailed Description
-----------------
A retrospective study was performed that assessed the time to significant analgesia and medications used to achieve analgesia in the DHMC ED. Based upon this a prospective pain management protocol was designed and we will track the difference in time to significant pain relief between the two groups.

Official Title
-----------------
An Analgesia Protocol for Acute Renal Colic in the DHMC Emergency Department

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Drug: Toradol
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney stone on stone protocol CT scan Acute pain from a kidney stone Exclusion Criteria: Age < 18 or > 65 Pregnant women Contraindications to NSAID's or opiates

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: Toradol|nan|
|Drug: Morphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to significant pain relief |  | Within emergency department | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal colic, pain, protocol, emergency department
Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.

Official Title
-----------------
Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention

Conditions
-----------------
Diabetes Mellitus, Type 2, Coronary Restenosis

Intervention / Treatment
-----------------
* Drug: Technetium Tc99m Sestamibi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II Diabetes on medication & angioplasty within the past 6 months. Exclusion Criteria: Myocardial infarction or repeat angioplasty with the past 5 months. Unable to perform exercise or pharmacologic stress test.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Technetium Tc99m Sestamibi|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus |  |  | 
| Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up. |  |  | 
| Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care). |  |  |
PEPITA Study: An Observational Study of Tarceva (Erlotinib) in Second Line in Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.

Official Title
-----------------
A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Non-Squamous Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically or cytologically confirmed advanced (Stage IIIB) or metastatic (Stage IV) squamous non-small cell lung cancer after failure of first-line platinum-based chemotherapy Patients for whom the treating physician has decided to initiate treatment with Tarceva Exclusion Criteria: Mixed non-small cell and small-cell lung carcinoma or mixed squamous cell carcinoma with predominant adenocarcinoma component Current participation in a clinical trial evaluating an anticancer treatment

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical/demographic patients characteristics at baseline |  | 2 years | 
| Treatment schedules: Dose/duration/modifications/interruptions |  | 2 years | 
| Overall survival |  | 2 years | 
| Safety: Incidence of adverse events |  | 2 years | 
| Quality of life: FACT-L version 4 questionnaire |  | 2 years |
Carpal Tunnel/Amyloidosis Blood Sample Study

Study Overview
=================
Brief Summary
-----------------
Carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients. This specimen collection protocol will allow the investigators to screen patients with carpal tunnel syndrome for amyloidosis.

Detailed Description
-----------------
The investigators propose to assess a high risk population of patients, those with carpal tunnel syndrome, and systematically assess them for Amyloid Light-chain (AL) amyloidosis and Transthyretin-Related Amyloidosis (ATTR) with simple laboratory blood tests. The combination of serum immunofixation electrophoresis together with serum free light chain (FLC) assay approaches 100% sensitivity for identifying the monoclonal protein underlying the illness in patients with AL amyloidosis. In addition to this, testing for transthyretin gene mutations will allow the investigators to identify patients with ATTR. The investigators believe this simple screening panel (serum immunofixation and serum FLC assay and transthyretin mutation analysis) may allow the investigators to identify patients early in the course of their disease, at which point the investigators can intervene with effective treatment and spare patients a significant amount of morbidity and mortality.

Official Title
-----------------
Collection of Peripheral Blood Samples From Patients With Carpal Tunnel Syndrome for Laboratory Screening of Amyloidosis

Conditions
-----------------
Carpal Tunnel Syndrome, Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients with diagnosed carpal tunnel syndrome based on Electromyography (EMG) results. 2. Patients with electrographic confirmation of median neuropathy at the wrist 3. Age ≥18 years 4. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients receiving hemodialysis 2. Known amyloidosis

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 |
| --- | --- |
| Carpal Tunnel Blood Draw<br>Participants with confirmed diagnosis of Carpal Tunnel Syndrome who will undergo blood draw for laboratory analysis for amyloidosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Identified with Amyloidosis | Number of carpal tunnel syndrome patients identified with amyloidosis, which will be stratified into mild, moderate or severe | Up to 5 years |
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess whether Near-Infrared Fluorescence/NIR Imaging perfusion alters intraoperative management of the flap or of the participant wound bed.

Official Title
-----------------
Near-infrared FluORescencE Assessment of Myocutaneous Flap Microperfusion for Gynecologic RecONstrucTion (FOREFRONT): A Pilot Study

Conditions
-----------------
Gynecologic Surgery

Intervention / Treatment
-----------------
* Diagnostic Test: ICG-NIR angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing a pelvic reconstruction procedure after radical gynecologic surgery for any indication at MSK. Age ≥18 years. Exclusion Criteria: Women with hepatic dysfunction as evidenced by elevated transaminases (two times the upper limit of normal). Women with a history of cirrhosis or other chronic liver disease. Women with a documented severe or life threatening allergy to iodine. Women with an allergy to ICG or severe allergy to iodinated contrast. Women undergoing any free flap (non-pedicled) reconstruction.

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 |
| --- | --- |
| Participants undergoing a pelvic or abdominal wall reconstruction procedure<br>Women undergoing a pelvic or abdominal wall reconstruction procedure after radical gynecologic surgery for any indication at Memorial Sloan Kettering Cancer Center | Diagnostic Test: ICG-NIR angiography<br>* Capture NIR video of flap site beginning at time of ICG injection. At time of subjective peak intensity, capture video of flap and recipient wound bed. Measure rate of ICG egress from the global flap at 60, 120, and 180 seconds after initial dye injection from intraoperative video<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans | The primary purpose of this study is to introduce ICG-NIR angiography in abdominopelvic skin and myocutaneous pedicle flap-based reconstruction during gynecologic oncology surgery and determine the percentage of cases in which intraoperative ICG-NIR angiography altered surgical flap reconstruction plans. | Up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICG, gynecologic surgery, abdominal wall reconstruction procedure, pelvic reconstruction procedure, Near-Infrared Fluorescence Imaging, 21-349, Memorial Sloan Kettering Cancer Center