linjc16/ctgov huggingface dataset:
Hostility and Pathogenic Mechanisms of Coronary Heart Disease in Women

Study Overview
=================
Brief Summary
-----------------
To determine the combined effects of hostility, harassment, lipids, and oral contraceptive (0C) use on physiological responses in young and middle-aged premenopausal women.

Detailed Description
-----------------
BACKGROUND: Preliminary findings already have shown that, in contrast to women with low scores on the Cook and Medley Hostility (Ho) scale, women with high Ho scores exhibit greater cardiovascular changes to harassment. Additional findings have suggested that oral contraceptive (0C) use may also be associated with increased behaviorally-induced physiological changes, especially in low Ho women. Similarly, higher levels of total serum cholesterol (TSC) have been positively associated with greater stress-induced neurohormonal changes in middle-aged men with high Ho scores. DESIGN NARRATIVE: Assessment of autonomic activity took place in the laboratory and during a 24 hour ambulatory measurement period. Hostility was measured with the Cook and Medley Hostility scale. The laboratory assessment helped to determine if high hostility women responded to harassment with greater cardiovascular and neurohormonal changes than low hostility women, and if this relationship was altered by 0C use, lipids, and age. The ambulatory assessment of autonomic activity allowed an exploration of the responses of high and low hostility subjects to daily-life stressors. Several hypothesis were explored: 1) Did harassment produce neuroendocrine as well as cardiovascular hyperreactivity in young women, and did this hyperreactivity generalize from laboratory to real-life? 2) Were the harassment-induced cardiovascular and neuroendocrine changes in young women also present in middle-aged women? 3) To what extent did 0C use modulate the cardiovascular and neuroendocrine responses to harassment in young women, and was 0C use also altering the hostility--related associations between lipids and reactivity? 4) Were the differential lipid-reactivity associations observed in middle-aged men as a function of high and low hostility scores present in women, and, if so, were they modulated by age? 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
-----------------
Heart Diseases, Cardiovascular Diseases, Coronary Disease

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

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

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

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 |
| --- | --- | --- |
MOSE to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions

Study Overview
=================
Brief Summary
-----------------
The technique of macroscopic on-site evaluation (MOSE) has recently been advocated for estimating the adequacy of a core specimen for histological diagnosis during EUS-FNA using a 19-gauge needle. How it compares to the conventional technique of tissue acquisition during EUS-FNA is uncertain. The objective of this study is to evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis.

Detailed Description
-----------------
To evaluate the quantity and quality of tissue, and the diagnostic ability of MOSE when compared with the conventional combined histologic-cytologic analysis in a randomized controlled study.

Official Title
-----------------
Macroscopic On-site Quality Evaluation of Biopsy Specimens to Improve the Diagnostic Accuracy During EUS-guided FNA Using a 19-gauge Needle for Solid Lesions: a Multicenter Prospective Randomized Controlled Study

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Procedure: Macroscopic on-site evaluation
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients (aged between 18 and 80 years) referred for EUS-guided tissue acquisition for intestinal or extra-intestinal solid lesions more than 2cm in the largest diameter would be included. Exclusion Criteria: Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Macroscopic on-site evaluation<br>EUS-FNA perform with a 19-gauge needle with macroscopic on-site evaluation. | Procedure: Macroscopic on-site evaluation<br>* Macroscopic on-site evaluation: any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). Length of MVC will be measured to determine the adequacy of that puncture.<br>|
| Sham Comparator: Control<br>EUS-FNA perform with a 19-gauge needle with conventional techniques. | Other: Control<br>* Conventional EUS-FNA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield: Proportion of patients with adequate tissue for diagnosis obtained by EUS FNA | proportion of patients with adequate tissue for diagnosis obtained by EUS FNA | 4 weeks |
Patient Preference With Visicol Tablet Preparation for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine patient preference and acceptance of tablet sodium phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their prior colonoscopy. This study will provide answers related to the patient preferences and their acceptance of this new method of bowel preparation.

Official Title
-----------------
Patient Preference and Acceptance With Sodium Phosphate Tablet Preparation for Colonoscopy: A Prospective Study

Conditions
-----------------
Preparation for Colonoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior colonoscopy with PEG solution in the past one year Must be able to swallow tablets Exclusion Criteria: Patients below 18 years and above 100 years. Congestive heart failure Chronic renal failure Pre-existing electrolyte disorder Pre-existing mega-colon or a motility disorder. Patients with pre-existing seizure disorder. Patients scheduled for colonoscopy after 1:00 p.m. will be excluded from the study. Pregnant or lactating women

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children

Study Overview
=================
Brief Summary
-----------------
Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults, Adolescents, and Children.

Official Title
-----------------
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages > 3 Years Old Exclusion Criteria: Severe Arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- | --- |
| Series of blood pressure measurements obtained in 100+ subjects |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol
Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.

Official Title
-----------------
Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Other: Growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: therapeutic need according to SPC written informed consent Exclusion Criteria: contraindications according to SPC
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Growth hormone<br>Children with growth hormone deficiency | Other: Growth hormone<br>* Drug given by prescription<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of ZOMACTON | measured by: body height, increase of body height per annum | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy measured by further parameters | measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors | Up to 5 years | 
| Safety of Zomacton and application device | measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory | Up to 5 years |
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications

Study Overview
=================
Brief Summary
-----------------
Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. However, whether it influences risk of other PPCs is unclear.

Official Title
-----------------
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications in Elective Spinal Surgery: a Retrospective Cohort Study

Conditions
-----------------
Spinal Fusion, Transfusion, Pulmonary Complication

Intervention / Treatment
-----------------
* Procedure: transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included if they underwent elective spine surgery (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020 Exclusion Criteria: combined anterior-posterior surgery growth rod adjustment surgery spinal tumor. surgery took fewer than 3 hours.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 82 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 |
| --- | --- |
| non-PPCs group<br>Patients without PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection) | Procedure: transfusion<br>* transfusion<br>|
| PPCs group<br>Patients with PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection) | Procedure: transfusion<br>* transfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between blood transfusion and postoperative pulmonary complications | Correlation between blood transfusion and postoperative pulmonary complications | 28 days after surgery |
Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

Study Overview
=================
Brief Summary
-----------------
This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.

Official Title
-----------------
Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.

Conditions
-----------------
Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Intervention / Treatment
-----------------
* Procedure: Primary sigmoid resection with end colostomy (Hartmann)
* Procedure: Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis Exclusion Criteria:
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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Primary sigmoid resection with end colostomy (Hartmann)|nan|
|Procedure: Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality and morbidity after emergency surgery |  | 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality and morbidity after elective restoration of intestinal transit |  | 30 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diverticulitis, hartmann, anastomosis
Evaluation of the Effectiveness of a Home Visiting Program for New Parents in New Mexico

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses clinically trained professionals to provide first-time parents with information, training, and access to resources designed to promote early childhood development. Services are free and may begin at any time during pregnancy or up to two months after the baby's birth and may continue until the child is three years old. In addition, a nurse postpartum home visit is offered to the parents of all participating newborns. The FBP model builds on other home visiting and prevention programs that have been shown to improve long-term outcomes of children and their families.

Official Title
-----------------
Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico

Conditions
-----------------
Infant Health Risk Factors

Intervention / Treatment
-----------------
* Behavioral: First Born® Program home visiting services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-time parent Mother is currently pregnant or child is less than two months old Lives within Santa Fe County, New Mexico Parent accepts referral to First Born Program Exclusion Criteria: Child is not first born First-born child is two months or older Parent resides outside Santa Fe County Parent has not been referred to First Born Program

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

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

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: Offered First Born® Program services<br>Family and first-born child are selected to be offered First Born® Program home visiting services. | Behavioral: First Born® Program home visiting services<br>* Family and first-born child are offered and/or receive weekly First Born® Program home visiting services between pregnancy and the child's third birthday. Families are eligible to enroll in the program from pregnancy up to two months after birth.<br>|
| No Intervention: Not offered First Born® Program services<br>Family and first-born child are not selected to be offered First Born® Program home visiting services. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with child health or development risk factors |  | First year of life |
Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if there is an effect on the pharmacokinetics of bosutinib when administered with lansoprazole.

Official Title
-----------------
A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Bosutinib
* Drug: Bosutinib
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women of nonchildbearing potential, between the ages of 18 to 50 years old. Exclusion Criteria: Any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: 1<br>Bosutinib | Drug: Bosutinib<br>* 4 x 100-mg oral tablets, single dose<br>* Other names: SKI-606;|
| Experimental: 2<br>bosutinib + lansoprazole | Drug: Bosutinib<br>* 4 x 100-mg oral tablets, single dose<br>* Other names: SKI-606;Drug: Lansoprazole<br>* 2 x 30-mg oral tablets, single daily doses for 2 days<br>* Other names: Prevacid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics as measured by Cmax, AUC, tmax, t1/2 |  | 1 month |
Perspectives of Receiving Open Versus Minimally Invasive Surgery

Study Overview
=================
Brief Summary
-----------------
This study will examine the perspectives of patients' undergoing surgery for lung or esophageal cancer. It will examine both pre-op and post-op patient perspectives and opinions regarding pain and surgical complications. This study will also assess a general health related quality of life pre-op and post-op. Additionally, it will examine the importance of receiving care close to home and their support system. Hypotheses: The data will allow investigators to better understand the willingness of patients to participate in prospective, randomized studies comparing minimally invasive and open thoracic surgery. Patients will not be willing to undergo randomization to an open versus minimally invasive surgical procedure. The pain associated with Minimally Invasive Surgery (MIS) will be perceived and documented as lesser than open surgery. Patients may be willing to accept a higher risk of complications or more post-operative pain if they were given the option to be cared for closer to their home.

Official Title
-----------------
Perspectives for Receiving Open Versus MIS (PROMIS) - Patients' Perspectives on Surgical Treatment of Lung and Esophageal Cancer

Conditions
-----------------
Lung Cancer, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are surgical candidates for lung or esophageal cancer (entered at pre-op time point) Exclusion Criteria: Below 18 years of age.

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 |
| --- | --- | --- |
| Change in pain perceptions | Patients will rate their perceptions of pain associated with surgery both pre-op and at 4 weeks and 6 months post-op. | Baseline, 4 weeks and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in general health related quality of life | Patients will rate their general health related quality of life at pre-op, and post-op (4 weeks and 6 months) time points. | Baseline, 4 weeks and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimally invasive surgery, Patient perspectives, Lung cancer, Esophageal cancer, Pain