linjc16/ctgov huggingface dataset:
Postop Pain in the MICS Patients Versus Sternotomy Patients

Study Overview
=================
Brief Summary
-----------------
To adequately assess postoperative pain in the coronary artery bypass surgical population a multicentered retrospective chart review was carried out; the study utilized a nonexperimental comparative descriptive study design. The retrospective review was conducted over a six-month time frame, consisting of June 2017 through November 2017, at two hospitals within the same organization. The data collection process began in late December of 2017 and January of 2018. The assessment of postop pain was performed by using a standard 11-point numeric pain rating scale on post extubation day one and the day of discharge.

Official Title
-----------------
Is Postoperative Pain Different in the MICS CABG Cohort V. the Traditional Sternotomy Cohort

Conditions
-----------------
Pain, Postoperative, Surgery

Intervention / Treatment
-----------------
* Procedure: Coronary bypass surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had an isolated coronary artery bypass surgery at Charlotte Medical Center (CMC) and CMC-Pineville Minimally invasive cardiac surgery Traditional sternotomy cardiac surgery Exclusion Criteria: Documented history of any chronic pain syndromes requiring active treatment The relative recent requirement of narcotic analgesic use for pain relief prior to operation Any CABG operation that inadvertently resulted in an operative surgical complication Patient cases that resulted in a readmission within 30 days from surgery.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Minimally Invasive Cardiac Bypass patients<br> | Procedure: Coronary bypass surgery<br>* Reviewed postoperative coronary bypass patients and compared postoperative pain levels<br>|
| Traditional Sternotomy Cardiac Bypass patients<br> | Procedure: Coronary bypass surgery<br>* Reviewed postoperative coronary bypass patients and compared postoperative pain levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest reported pain level, on the standard 0-10 pain scale, post extubation day one | The highest recorded pain level, taken by the nursing staff, on the day following. extubation. Utilized day post due to the washout/possible confounding variable of sedation administration within 24hrs. | The first 24 hours post extubation | 
| Highest reported pain level, on the standard 0-10 pain scale, on the day of discharge. | The highest reported pain, measured by the nursing staff on within 24hrs from discharge. | Within 24 hours from discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimally invasive, Cardiac Surgery, Postoperative Pain
Surgical Treatment of Long Bone Metastases

Study Overview
=================
Brief Summary
-----------------
To provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

Detailed Description
-----------------
The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Official Title
-----------------
Surgical Treatment for Long Bone Metastases With Intramedullary Nail or Endoprosthetic Reconstruction

Conditions
-----------------
Bone Metastases, Surgery

Intervention / Treatment
-----------------
* Procedure: intramedullary fixation or endoprosthetic reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bone metastases of the extremity Exclusion Criteria: bone metastases of the spine
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: intramedullary fixation or endoprosthetic reconstruction|Surgical treatment of impending or pathologic fracture in the extremities|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction | The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary nail versus endoprosthetic reconstruction with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival in patients undergoing surgery for metastatic bone disease | Provide a reliable and objective means of estimating survival in patients with metastatic bone disease based on disease-specific | 1 year |
Database Study on Patients With PCOS

Study Overview
=================
Brief Summary
-----------------
All newly referred patients with PCOS and hirsutism are listed in a database.

Detailed Description
-----------------
All premenopausal women referred to the outpatient clinic at the Department of Endocrinology from 1997 and onward with the referral diagnoses hirsutism and/or PCOS are included in a clinical database. The patients should fulfill the Rotterdam criteria for PCOS or have clinical/biochemical hyperandrogenemia. Routine evaluation include medical history, clinical examination, transvaginal ultrasound (US), and fasting blood samples. Cycle history is recorded in all patients using a standard scheme prepared for hirsute patients. Blood tests include androgens, LH, FSH, prolactin, and lipid profile. OGTT and ACTH are performed in high risk patients

Conditions
-----------------
PCOS, Hirsutism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premenopausal hirsutism or PCOS

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 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 |
| --- | --- |
| PCOS and hirsutism<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.

Official Title
-----------------
A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: ALIMTA plus Epirubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment. Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy. Patients must have at least one measurable lesion in an area not previously irradiated. No chemotherapy at least 4 weeks prior to study enrollment. Signed informed consent from patient. Exclusion Criteria: Treatment with any drug within the last 30 days that has not received regulatory approval. Serious systemic disorders, including active infection. Significant cardiovascular disease. Pregnancy or breast feeding. Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

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: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALIMTA plus Epirubicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the influence of Orlistat and Metformin on obesity treatment in obese PCOS women.

Detailed Description
-----------------
In a randomized clinical trial study, 80 obese women with BMI≥30, oligomenorrhae, hirsutism and presence of > 12 ovarian follicles (2-10mm diameter), were evaluated. In metformin group , metformin was administered for patients 1500 mg daily for three months. In orlistate group, patients used orlistat tablets (120 mg, 3 times a day) for three months. BMI, serum LH and FSH levels, serum triglyceride and cholesterol levels and also patients' ovulation was compared before and after treatment.

Official Title
-----------------
Orlistat Administration Facilitates the Obesity Treatment Among Obese PCOS Women

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: orlistat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>= 30 PCOS Exclusion Criteria: Drug use during last three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orlistat<br>The dose of 120 mg orlistat was taken three times daily and the dose remained constant throughout the study period. | Drug: orlistat<br>* Tablet,120mg,three times a day,three months<br>* Other names: Xenical;|
| Experimental: Metformin<br>The dose of metformin was increased step - wise, from 500 mg once daily for the first week to 500 mg twice daily for the next week, and to 500 mg three times daily for the remaining study period . | Drug: orlistat<br>* Tablet,120mg,three times a day,three months<br>* Other names: Xenical;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulatory |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metformin, orlistat, pcos, obese
An Efficacy and Safety Study of Omacor® in Taiwanese Hypertriglyceridemic Patients

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy of Omacor® in Taiwanese hypertriglyceridemia patients Evaluation of the safety of Omacor® in Taiwanese hypertriglyceridemia patients

Detailed Description
-----------------
The primary end point is to evaluate the efficacy and safety of Omacor in Taiwanese hypertriglyceridemia patients.

Official Title
-----------------
A Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of Omacor® in Taiwanese Hypertriglyceridemic Patients

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Omacor®
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has fasting serum TG ≥ 200 mg/dL but no more than 1000 mg/dL Exclusion Criteria: Patients had a history of pancreatitis or considered to be at risk of developing pancreatitis Patient had history of a severe cardiovascular event or a revascularization procedure within 6 months prior to randomization

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omacor® 4 g<br>Subjects in this group will take 4 g of Omacor® everyday. | Drug: Omacor®<br>* Subjects in 4 g and 2 g Omacor® will take this drug<br>* Other names: Omega-3-acid ethyl ester 90;|
| Active Comparator: Omacor® 2 g<br>Subjects in this group will take 2 g of Omacor® and 2 g of placebo everyday. | Drug: Omacor®<br>* Subjects in 4 g and 2 g Omacor® will take this drug<br>* Other names: Omega-3-acid ethyl ester 90;|
| Placebo Comparator: Placebo<br>Subjects in this group will take 4 g of placebo everyday. | Drug: Placebo<br>* Subjects in placebo group will take this drug<br>* Other names: Olive oil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Triglycerides from baseline |  | baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertriglyceridemia, omega-3-acid ethyl ester
Transcutaneous PCO2 Assessment During Intubation in ICU

Study Overview
=================
Brief Summary
-----------------
PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

Detailed Description
-----------------
Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.

Official Title
-----------------
Transcutaneous PCO2 Assessment During Intubation in ICU

Conditions
-----------------
Intubation in ICU

Intervention / Treatment
-----------------
* Procedure: PtcCO2 measure during intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient 18 years of age or older Requiring intubation in Resuscitation Exclusion Criteria: Contraindication to orotracheal intubation Intubation in a respiratory or cardiocirculatory arrest situation Need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration Major Incapable Opposition of the patient or his relatives to the research

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard Oxygen<br>preoxygenation methods : Standard Oxygen | Procedure: PtcCO2 measure during intubation<br>* Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature<br>|
| High flow Oxygen<br>preoxygenation methods : High flow Oxygen | Procedure: PtcCO2 measure during intubation<br>* Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature<br>|
| Non invasive ventilation<br>preoxygenation methods : Non invasive ventilation | Procedure: PtcCO2 measure during intubation<br>* Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous carbon dioxide partial pressure variation during intubation | Transcutaneous carbon dioxide partial pressure (TcPO2) variation during intubation in ICU and within 4 hours after intubation | 4 hours after intubation (the day of inclusion) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcutaneous PCO2, Preoxygenation, Post-intubation hypotension, ICU
A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects

Study Overview
=================
Brief Summary
-----------------
This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability. The way the human body processes GSK376501 will also be determined.

Detailed Description
-----------------
A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study with Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)

Official Title
-----------------
A Single-Blind, Randomized, Placebo Controlled, Ascending Single and Repeat Dose Study With Once Daily Dosing to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK376501 and to Evaluate Food Effects and the Relative Bioavailability of a Tablet Formulation Compared to the Powder for Reconstitution Formulation in Healthy Overweight and Obese Subjects (DIX109177)

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: GSK376501


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Healthy Non-smoking Overweight or obese subjects with a BMI between 27 and 35. Exclusion: Women who are pregnant, lactating, or are of child-bearing potential

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: placebo|nan|
|Drug: GSK376501|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be monitored by assessing adverse reactions,changes in laboratory values (hematology, clinical chemistry, urinalysis),changes in vital signs (oral body temperature,60 second respiratory rate, blood pressure and heart rate), and ECG changes. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of GSK376501 Effects of GSK376501 on the body, by measuring changes in insulin, glucose, and other markers |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GSK376501,, First Time in Human,, Single Dose,, Dose Escalation,, Healthy Overweight/Obese Volunteer
Chronic Life Stress and Incident Asthma in Adult Women

Study Overview
=================
Brief Summary
-----------------
To prospectively examine the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women.

Detailed Description
-----------------
BACKGROUND: Etiologies of the rising prevalence and morbidity of asthma are not well understood. Knowledge gaps are particularly significant with respect to adult-onset asthma. The role of stress in the expression of asthma is largely unexplored in large-scale, prospective, epidemiologic studies and such investigation has been identified as a priority by a recent NHLBI expert panel. DESIGN NARRATIVE: The study prospectively examines the association between a specific chronic life stressor (i.e., intimate violence exposure) and adult asthma in women participating in the Nurses' Health Study II cohort. Emerging epidemiologic data suggest that exposure to intimate violence is a pervasive chronic life stressor associated with adverse impact on womens' psychological and physical health. Traumatic stress such as that related to intimate violence exposure has been associated with neuroendocrine changes known to cause alterations in neuroendocrine and immune functions important to the pathophysiology of inflammatory diseases including asthma. The investigators are testing the hypothesis that women exposed to high-level chronic stress (violence) will be at greater risk for asthma development than women with low-level stress (violence) exposure. The influence of chronic stress on neuroendocrine and immune function as reflected in morning cortisol expression, for the former, and cytokine profiles and IgE production (T-helper cell polarization), for the latter, will also be examined in a nested case control fashion among these women. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |