linjc16/ctgov huggingface dataset:
The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction

Study Overview
=================
Brief Summary
-----------------
The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction

Official Title
-----------------
The Effectiveness of Adopting Humanized Service Program on Transabdominal Ultrasound About Pregnant Women's Service Quality and Satisfaction

Conditions
-----------------
Pregnant Women

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult over the age of 20 pregnant women. Clear consciousness, those without severe cognitive impairment, such as dementia, mental retardation or mental illness. Literacy and the use of Chinese or Taiwanese. Willingness to participate in the research. Exclusion Criteria: Refused to participate in the research

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
Chest Computed Tomography (CT) Screening Study With Antibody Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the value of EarlyCDT-Lung test and CT scan both in lung cancer detection and potential health economic outcomes.

Detailed Description
-----------------
EarlyCDT-Lung test and CT scan both for lung cancer detection and potential economic outcomes.

Official Title
-----------------
Different Strategies Using Autoantibodies and/or CT in the Detection of Lung Cancer

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Persons 50-75 Asymptomatic for lung cancer Current or former (stopped smoking less than 10 years ago) cigarette smokers History of cigarette smoking of at least 20 pack years History of cigarette smoking with a family history of lung cancer which gives an individual a personal risk similar to a smoking history of 20 pk/years (i.e. 1% at 5 years). Mentally competent individuals to sign an informed consent. Healthy enough to undergo pulmonary resection or stereotactic body radiotherapy. A fully informed signed consent form must have been obtained.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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
-----------------
CDT-Lung,CT scan,lung cancer detection
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Detailed Description
-----------------
Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of a therapeutic DNA vaccine (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when administered by Particle Mediated Epidermal Delivery (PMED)

Official Title
-----------------
A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator , Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers

Conditions
-----------------
HSV-2

Intervention / Treatment
-----------------
* Biological: pPJV7630 with pPJV2012 administered by PMED


Participation Criteria
=================
Eligibility Criteria
-----------------
Otherwise healthy subjects with seronegative HSV-2

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: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pPJV7630 with pPJV2012 administered by PMED|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity of vaccine post vaccination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA vaccine, immunotherapy, HSV-2, PMED
Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.

Official Title
-----------------
A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Levamlodipine besylate
* Drug: Amlodipine maleate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients, 18-75 Years Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and < 180mm/110mmHg) Written informed consent Exclusion Criteria: Patients with secondary hypertension Patients with severe hypertension Have to take other drugs that can influence blood pressure during the study Allergic to DHP calcium antagonists Evidence of congestive heart failure, unstable angina or severe arrhythmia Renal or hepatic dysfunction Women who are taking contraceptive pills or are likely to be pregnant Participate in other clinical trials within 3 months prior to this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levamlodipine besylate (2.5mg)<br> | Drug: Levamlodipine besylate<br>* Once daily, 7AM - 10AM<br>|
| Experimental: Levamlodipine besylate (5mg)<br> | Drug: Levamlodipine besylate<br>* Once daily, 7AM - 10AM<br>|
| Active Comparator: Amlodipine maleate (5mg)<br> | Drug: Amlodipine maleate<br>* Once daily, 7AM - 10AM<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure (SBP) |  | Week 8 | 
| Change from baseline in diastolic blood pressure (DBP) |  | Week 8 | 
| Incidence of adverse effects |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essential Hypertension, Levamlodipine Besylate, Amlodipine Maleate
The Effect of Virtual Reality Glasses on Labor Pain

Study Overview
=================
Brief Summary
-----------------
There are different medicinal and non medicinal methods to control labor pain. Today, much attention has been on non medicinal methods because of limitations and complications of medical procedures. Virtual reality is a new and promising method of diversion of mind that may have an impact on labor pain. This study was conducted to determine the effect of virtual reality on the first stage of labor pain.

Official Title
-----------------
Principal Investigator

Conditions
-----------------
Anxiety, Labor Pain

Intervention / Treatment
-----------------
* Device: three-dimensional glasses(manufactor Vuzix,wrap 920)
* Other: usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iranian low risk pregnancy primipara Exclusion Criteria: vision or ear disorders History of motion sickness or headaches psychological disease or Addiction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: three-dimensional glasses (Virtual Reality glasses)<br>Women in case group used the glasses for 30 minutes | Device: three-dimensional glasses(manufactor Vuzix,wrap 920)<br>* The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.<br>|
| Experimental: usual care<br>Women in control group did not use the glasses. | Other: usual care<br>* Women in Control group did not use the glasses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain and anxiety |  | up to 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor pain, Virtual reality, the first stage of labor, Pain relief, Simulator
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if what you eat affets your insulin sensitivity when you lose a small amount of weight

Official Title
-----------------
The DINE Study-Diet Intervention to Negate Diabetes Study (Improving Weight Loss Outcomes for African Americans)

Conditions
-----------------
Diabetes, Hypertension, Insulin Resistance

Intervention / Treatment
-----------------
* Behavioral: The DASH diet with weight loss
* Behavioral: The DASH diet without weight loss
* Behavioral: Dairy diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American adults (age ≥ 19) Obese (BMI > or equal to 30 kg/m2) Otherwise generally healthy Exclusion Criteria: Diagnoses of diabetes Malignancy or other states where weight loss is contraindicated (pregnancy Individuals with high blood pressure on medications.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weight loss<br>Weight loss diet focused on the DASH diet | Behavioral: The DASH diet with weight loss<br>* A reduced calorie diet is provided to participants based on the DASH diet.<br>|
| Active Comparator: DASH diet<br>The DASH diet without weight loss | Behavioral: The DASH diet without weight loss<br>* participants are given a weight maintainenance diet based on the DASH diet<br>|
| Active Comparator: Diary<br>Dairy Intervention | Behavioral: Dairy diet<br>* participants are given a high dairy, reduced calorie diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity |  | 8 weeks |
Evaluation of Kidney Disease in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
A non-invasive urinary test that detects kidney injuries in liver transplant (LT) candidates would be useful for monitoring of kidney damage. Particularly, the ability to predict irreversibility of such renal damage or progressive nature of renal disease in LT candidates would be of importance to determine the need for dual kidney-liver transplantation (KLT) versus LT alone. We will correlate kidney histology with cytokine/chemokine profile expression in the urine as a potentially useful noninvasive diagnostic tool.

Official Title
-----------------
Kidney Disease in Advanced Liver Disease Patients: A Study of Kidney Damage by a Urinary Cytokine/Chemokine Multiplex Assay

Conditions
-----------------
Kidney Disease, Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects on the liver transplant wait list, subjects who have received a liver transplant at least 6 months prior to enrollment, or subjects who have normal liver function and are about to undergo kidney biospy for diagnostic purposes. Exclusion Criteria: Contraindication to kidney biopsy Inability to give informed consent

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 |
| --- | --- |
| 1<br>ESLD subjects on active liver transplant waiting list | |
| 2<br>Subjects post-liver transplant with good liver function | |
| 3<br>Subjects without liver disease undergoing kidney biopsy for diagnostic purposes | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the value of urinary levels of chemokines in the distinction between types of kidney disease in the setting of liver failure |  | 1 year |
Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric subjects

Detailed Description
-----------------
The purpose of this study is to determine the pharmacokinetics profile of ceftaroline in pediatric subjects

Official Title
-----------------
Pharmacokinetics of a Single Dose of Ceftaroline in Subjects 12 to 17 Years of Age Receiving Antibiotic Therapy

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: ceftaroline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized and receiving antibiotic therapy for treatment of a suspected infection of any type Body mass index (weight [kg]/height squared [m2]) of no more than 30 Males and females between 12 and 17 years of age, inclusive Exclusion Criteria: History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial Past or current history of epilepsy or seizure disorder Critically ill or unstable patients

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>ceftaroline | Drug: ceftaroline<br>* Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.<br>* Other names: ceftaroline fosamil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Maximum Plasma Concentration (Cmax) of Ceftaroline After Administration of Ceftaroline Fosamil at a Dose of 8 mg/kg up to a Maximum Dose of 600 mg Via IV Infusion Over 60 Minutes. | The maximum plasma concentration (Cmax ) occurred around the time of the end of study drug infusion. | 12 hours after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) Reported After Starting Study Drug Administration (Treatment Emergent Adverse Events, TEAEs) by Relationship to Ceftaroline (Related or Unrelated). | A TEAE is any untoward medical occurrence a subject experiences following study drug administration. Subjects were monitored for TEAEs from the start of infusion of ceftaroline fosamil on Study Day 1 through the follow-up contact on Day 7. | Signing of Informed Consent Form (ICF) to last follow up (FU) visit, study day 7 (+-2 days). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PK, Pharmacokinetics
Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer. In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.

Official Title
-----------------
Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing appendectomy due to appendicitis; 6-36 months after appendectomy; Patients with no obvious abnormality observed by colonoscopy; Age between 20 and 85. Exclusion Criteria: A. Any history of malignancy or disease Any inflammatory bowel disease (IBD) prior to study inclusion; Antibiotics and hormone drugs taken within the last three months; Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.); Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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 |
| --- | --- |
| The appendectomy group<br> | |
| Colorectal cancer group<br> | |
| Normal group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Species composition of fecal microbial | The types of microorganisms of fecal microbial | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight in kilograms | weight of enrolled patients | baseline, pre-procedure | 
| height in meters | height of enrolled patients | baseline, pre-procedure | 
| age in year | age of enrolled patients | baseline, pre-procedure |