linjc16/ctgov huggingface dataset:
Association of Anemia With Hospital Costs in Elective Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The objective is to measure the adjusted association between preoperative anemia and total hospital costs. We hypothesize that patients with anemia before surgery will have higher hospitalization costs than people without anemia.

Detailed Description
-----------------
This study will examine the association between preoperative anemia (hematocrit less than 0.39; low blood counts) and hospital total costs from elective colorectal surgery. Total costs will be defined as the combination of direct and indirect costs ascertained using standardized patient-level costing algorithms (i.e. the standard way that hospital measure their costs). Adjustment will be made for factors that are likely to influence both the presence of anemia and costs of care.

Official Title
-----------------
Association of Anemia With Hospital Costs in Elective Colorectal Surgery

Conditions
-----------------
Surgery, Surgical Blood Loss, Anemia, Colon Cancer, Economic Problems

Intervention / Treatment
-----------------
* Other: Anemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective hospital admission having colorectal surgery Exclusion Criteria: not enrolled in national surgical quality improvement program data collection

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 |
| --- | --- |
| Anemic<br>People with a preoperative hematocrit less than 0.39 | Other: Anemia<br>* Hematocrit less than 0.39<br>|
| Non-anemic<br>People with a preoperative hematocrit greater than or equal to 0.39 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hospital costs | Direct and indirect costs accrued during the index hospitalization | Hospital admission to date of discharge from hospital, or 365 days after admission, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Number of days in hospital after surgery | Date of surgery to date of hospital discharge, or up to one year after surgery (whichever comes first) | 
| Red blood cell transfusion | Any red blood cell transfusion received | Hospital admission to date of surgery, or 365 days after admission, whichever came first |
Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.

Official Title
-----------------
Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy

Conditions
-----------------
Sars-CoV2

Intervention / Treatment
-----------------
* Diagnostic Test: biological samples day of delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant woman diagnosed with Sars Cov-2 during pregnancy singleton or twin pregnancy informed consent Exclusion Criteria: virological or serological samples not done the day of delivery

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

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

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: pregnancy patients diagnosed with SARS Cov2 during pregnancy<br>Delivery day biological samples from the mother and the newborn will be performed | Diagnostic Test: biological samples day of delivery<br>* mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vrological profile of newborns. | Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid- | day of delivery | 
| Immunological profile of newborns. | Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence | day of delivery |
CNAP Accuracy in the Bariatric Surgery Population

Study Overview
=================
Brief Summary
-----------------
This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).

Conditions
-----------------
Bariatric Surgery

Intervention / Treatment
-----------------
* Device: CNAP monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity Patients in whom an indwelling arterial cannula will be placed for the surgical procedure Exclusion Criteria: Patients with history of a peripheral neurologic or neuropathic disorder Patients in whom an invasive arterial cannula cannot be placed Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm) Edematous patients
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNAP monitor<br>Subjects undergoing bariatric surgery and monitored using the CNAP monitor. | Device: CNAP monitor<br>* Patients undergoing bariatric surgery and being monitored using the CNAP monitor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP. | To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg. | Participants will be followed for the duration of surgery, an expected average of 2 hours. |
Secondary PRevention in Cardiovascular Disease by a Nursing Guide Program (SPRING)

Study Overview
=================
Brief Summary
-----------------
DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric. CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored not supervised. MAIN OBJECTIVE: To determine the incidence of major adverse cardiac events, MACE (total mortality, new ACS, coronary revascularization, all-cause hospitalization) during the one-year period after hospitalization for ACS.

Official Title
-----------------
Secondary PRevention in Cardiovascular Diseaseby a Nursing Guide Program. SPRING Trial

Conditions
-----------------
Acute Coronary Syndrome, Nutrition, Physical Activity

Intervention / Treatment
-----------------
* Behavioral: INTERVENTION GROUP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have suffered an ACS in the health area of A Coruña from the beginning of the study inclusion period until reaching the fixed sample size. Ages between 18 and 75 years. Patients with ability to read and understand the participation sheet in the study. Patients signing informed consent to participate in the study. Patients living in the health care area of HUAC. Patients who possess and know how to operate with a smart mobile phone (Smartphone type). Exclusion Criteria: Patients who are dependent for the Basic Activities of Daily Living (BADL) or who suffer from severe cognitive impairment (which makes reliable anamnesis impossible). Patients with a Left Ventricular Ejection Fraction (LVEF) less than or equal to 30%. Patients with a NYHA III / IV score and / or the Canadian Cardiovascular Association (CCS) scale of IV.

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 |
| --- | --- |
| Active Comparator: INTERVENTION GROUP<br>The participants of this group will follow recommendations of food, physical exercise, control of consumption of drugs and consumption of alcohol and tobacco. | Behavioral: INTERVENTION GROUP<br>* Offer recommendations of healthy living habits and control of pharmacy administration<br>|
| No Intervention: CONTROL GROUP<br>The participants of this group are submitted to the standard intervention. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events | (total mortality, new ACS, coronary revascularization, hospitalization for any cause) | 2 years |
Cardiac SPECT With Rotating Slant Hole Collimator

Study Overview
=================
Brief Summary
-----------------
The goal is to conduct a clinical pilot study to evaluate the use of a rotating multi-segment slant-hole collimator in the detection of myocardial defects.

Detailed Description
-----------------
Myocardial perfusion SPECT is recognized as an effective clinical diagnostic imaging technique in the assessment of myocardial perfusion and coronary artery diseases. It is the most important clinical application of SPECT imaging techniques. The goal is to conduct a clinical pilot study to evaluate the use of rotating multi-segment slant-hole (RMSSH) SPECT in the detection of myocardial defects especially in very sick patients in the nuclear medicine clinics, emergence room, and intensive care units. Comparison of the clinical utilities of the cardiac RMSSH SPECT technique with conventional cardiac planar and SPECT with parallel-hole collimation will also allow us to evaluate the potential application of the technique to a wider patient population. The objective of this study is to test the hypothesis that quantitative 99mTc myocardial perfusion RMSSH SPECT provides similar diagnostic accuracy in patients with cardiac diseases as conventional SPECT imaging techniques.

Official Title
-----------------
Myocardial Perfusion SPECT Using a Rotating Multi-segment Slant-hole Collimator

Conditions
-----------------
Coronary Artery Diseases, Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females 18-80 who are scheduled for a clinical Cardiac Stress Test Exclusion Criteria: Pregnant Women and Children

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Myocardial Perfusion SPECT
Breast, Omega 3 Free Fatty Acid, Ph 0

Study Overview
=================
Brief Summary
-----------------
Assess the impact of dietary omega 3 free fatty acids breast cancer patients.

Detailed Description
-----------------
Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).

Official Title
-----------------
A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)

Conditions
-----------------
Breastcancer

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 FFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age ECOG ≤2 Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Consented for tissue collection on CTRC repository 07-32 Exclusion Criteria: Active systemic illness (infection including viral illnesses such as Hepatitis and HIV) Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days) Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days History of medical noncompliance Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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: Omega-3 FFA<br>Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner). | Dietary Supplement: Omega-3 FFA<br>* Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.<br>* Other names: Omacor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum colony stimulating factor at surgery |  | 30 days | 
| Change in circulating levels of pro-inflammatory cytokines. |  | 30 days | 
| Change in circulating levels of eicosanoids. |  | 30 days | 
| Change in circulating levels of metabolics. |  | 30 days |
Pharmacokinetic Investigation of UDCA in Bile and Serum

Study Overview
=================
Brief Summary
-----------------
To assess the bile acid composition of cystic bile and serum pharmaco¬kinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameters of UDCA in bile and serum during steady state.

Detailed Description
-----------------
see protocol

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: UDCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PBC or healthy Exclusion Criteria: pathology which does interfere with safety or PK of UDCA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UDCA|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
-----------------
PK analysis
Renal and Cardiovascular Effects of Terlipressin in Patients With Cirrhosis and Ascites

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of terlipressin on myocardial perfusion and renal function. Hypothesis: Significant improvement of renal function reflected by: glomerular filtration rate (GFR), renal blood flow (RBF), excretion of salt and metabolites in the urine and related hormones and peptides in the blood. No effect on the systolic function of the heart.

Conditions
-----------------
Ascites, Cirrhosis

Intervention / Treatment
-----------------
* Drug: Terlipressin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis and ascites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This study aims to characterize clonal evolution in chronic lymphocytic leukemia (CLL) using different approaches and to identify a possible association with disease progression, i.e. therapy initiation. Samples This monocentric study is carried out using representative bioarchived leukemic samples with a diagnosis of CLL, either at diagnosis or at evolution. These bioarchived samples were collected locally at our center during years of diagnostic activity, and were accurately pathologically, cytogenetically and molecularly characterized. Clinical data The clinical data were retrospectively collected through collaboration with the referring physicians. Methods Samples will be investigated by means of (1) conventional cytogenetics, (2) fluorescence in situ hybridization (FISH) and (3) SNP-arrays. After analysis of the array data sets, significant results will be validated and in addition, results will be correlated with clinical data.

Official Title
-----------------
Genomic Analysis of Patients With Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of CLL, at least two available stored samples Exclusion Criteria: at least one inclusion criterium not fulfilled
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLL<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to therapy | Time from diagnosis to the start of first line therapy | baseline to day 1 of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic abnormalities detected by karyotyping, FISH or array-analysis | Detection of any type of genetic abnormality or pattern of abnormalities present at diagnosis or at time of disease progression (e.g. median 41 months after diagnosis, range 13-102 months) by means of karyotyping, fluorescent in situ hybridization or array-analysis. | 13-102 months |
Audio Recording for Improved Surgical Outcome (ARISO)

Study Overview
=================
Brief Summary
-----------------
Use of audio recordings (with suggestions and imagery for a better surgical outcome) studied in orthopedic patients.

Detailed Description
-----------------
Pt undergoing orthopedic surgery are randomized into 3 groups. These interventionals will be listening to CD recording just prior to and during orthopedic surgery. The 2nd group will be listening to a recording before and during surgery without any positive suggestions. The 3rd group will be receiving usual care. Prior to hospital discharge patients will fill out a questionaire assessing their perception of their surgery and hospital stay. Pt. charts will be reviewed for use of pain, sleep, anesthesia and nausea medication and for the number of units of blood transfused. Pt. outcomes will be asssessed with this data.

Official Title
-----------------
Audio Recording for Improved Surgical Outcome

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Audio recording


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for total hip replacement under reginal anethesia at Mayo Clinic in Jacksonville, Fl. Willingness to sign consent. Age 18 or greater.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A/B/C<br>Patients are randomized to voice/music/ or no CD | Behavioral: Audio recording<br>* Using audio recording to investigate if possitive affirmations help with pain management and other post of compllication.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Op pain |  | Day 1 to 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Loss, Nausea, sleep |  | Day 1 to Day 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Surgery, Perioperative, suggestions/imagery