linjc16/ctgov huggingface dataset:
Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.

Study Overview
=================
Brief Summary
-----------------
This study evaluates, if the movement of the cervical spine, assessed via a specific questionnaire by the patient, is a valid and reliable tool and could be used in daily clinical routine.

Detailed Description
-----------------
Cervical range of motion is a frequently used assessment methods in patients with neck pain. Although it seems to be used frequently, clinicians still prefer hands-on assessment. Furthermore it is interesting, if cervical range of motion,self-assessed by the patient is a valid and reliable tool.

Official Title
-----------------
Development of a Self-administered Neck Mobility Assessment Tool in Chronic Neck Pain Patients.

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Other: Cervical range of motion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neck pain > 90 days Able to speak, read and write German Exclusion Criteria: Red Flags e.g. Fracture of the cervical spine

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

| Intervention/Treatment |
| --- |
|Other: Cervical range of motion|Patients will fill out the Neck Disability Index, Visual Analogue Pain Rating Scale and the Self-administered Neck range of motion questionnaire.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Spine Mobility | Patients will fill out the questionnaire once, at the beginning of the study. | Day one of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analogue Pain Rating Scale | Patients will fill out the questionnaire once, at the beginning of the study. | Day one of the study | 
| Disability on Neck Disability Index | Patients will fill out the questionnaire once, at the beginning of the study. | Day one of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic
Multi-Compression Spot Mammography

Study Overview
=================
Brief Summary
-----------------
In this study, participants, who are scheduled to have a breast biopsy, will have several extra spot mammogram images taken of the suspicious area. These images will be acquired with varying levels of compression. The images will then be analyzed to determine whether the type of lesion (malignant or benign) can be determined from the image data alone. The biopsy results will be used as a gold standard to determine the true malignancy status

Official Title
-----------------
Multi-Compression Spot Mammography

Conditions
-----------------
Breast Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 45 years and older Women with suspicious mammography findings requiring a biopsy Exclusion Criteria: Men Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast mass, Breast lesion
The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.

Official Title
-----------------
The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documentation of informed consent and authorization. Full term and late preterm newborns (EGA 35-44 weeks) On room air Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth Parents agree to follow-up contact post discharge Exclusion Criteria: On supplemental oxygen Admitted to the Neonatal Intensive Care Unit Parents do not agree to follow-up Greater than 30 days of age

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Congenital Heart Defect<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True Positive Rate | The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD. | One year follow-up | 
| False Positive Rate | The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts. | One year follow-up | 
| True Negative Rate | The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts. | One year follow-up | 
| False Negative Rate | The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects. | One year follow-up |
Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine

Study Overview
=================
Brief Summary
-----------------
This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).

Detailed Description
-----------------
This study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for Taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated). It also analyses costs from a societal perspective.

Official Title
-----------------
Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model

Conditions
-----------------
Human Papillomavirus Infection

Intervention / Treatment
-----------------
* Other: Prevalence-based model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group). Exclusion Criteria: Not applicable.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV-1 Group<br>Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan. | Other: Prevalence-based model<br>* Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).<br>|
| HPV-2 Group<br>Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan. | Other: Prevalence-based model<br>* Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual number of lesions prevented by each vaccine |  | Over a one-year period | 
| Lesion related total cost averted by each vaccine |  | Over a one-year period | 
| Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine |  | Over a one-year period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gardasil, Prevalence-model, Cervarix, economic, health
Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy

Detailed Description
-----------------
Post operative nausea and vomitting is Avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting

Official Title
-----------------
Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy

Conditions
-----------------
Nausea and Vomiting, Postoperative

Intervention / Treatment
-----------------
* Drug: Granisetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia Exclusion Criteria: patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group G<br>will receive granisteron 1mg after induction of general anesthesia | Drug: Granisetron<br>* The drug is given after induction of general anesthesia<br>* Other names: Granitryl;|
| Placebo Comparator: Group C<br>Will receive metoclopramide 10 mg after induction of general anesthesia | Drug: Granisetron<br>* The drug is given after induction of general anesthesia<br>* Other names: Granitryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomitting | Number of attacks of nausea and vomitting | Every 2 hours for 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic cholecystectomy
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To examine nipple aspirate fluid for secretions that may be identified as a high risk indicator for development of breast cancer, and compare those to serum analysis.

Detailed Description
-----------------
To examine nipple aspirate fluid analysis in lactating women for local concentration of estrogen, prolactin, glucocorticoids, insulin, parity, prior lactation and age. NAF secretors have been reported to have modest increase in breast cancer risk compared to non-secretors . Estrogen levels have been found to be markedly higher in NAF samples than in the serum collected from the same women. Estradiol and estrone concentrations in premenopausal women are 10x and 20x greater in NAF samples than in serum and 50x and 35x greater in post-menopausal women not on HRT. It has been suggested that the disparity between serum and NAF levels may be due to local estrogen production via aromatase and sulfatase.

Official Title
-----------------
Study of Manual Nipple Fluid Aspiration IN Post-Menopausal Women

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with high a high risk of breast cancer Older than 18 Exclusion Criteria: anticoagulants marked breast tenderness pregnant or within twelve months of breast feeding/childbirth

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

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

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
-----------------
NAF, nipple aspirate fluid, breast atypia, high risk for breast cancer, breast epithelial hyperplasia, Ki-67, hormones plus chemoprevention, chemoprevention
ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTA alone on you and your malignant pleural mesothelioma as well as make ALIMTA available to patients who qualify for treatment.

Conditions
-----------------
Mesothelioma

Intervention / Treatment
-----------------
* Drug: Pemetrexed
* Drug: Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a proven diagnosis of malignant mesothelioma in patients not candidates for curative surgery Prior chemotherapy for your disease is allowed Measurable lesion is not required Have a adequate performance status Sign an informed consent form Exclusion Criteria: You are excluded from this trial if you have received any investigational agent within 4 week before enrolling in this study You are excluded from this trial if you have received radiation within the previous 2 weeks You are excluded from this trial if you are a candidates for curative surgery

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

| Intervention/Treatment |
| --- |
|Drug: Pemetrexed|nan|
|Drug: Cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see how effective bioelectric impedance analysis (BIA) is in determining body composition (the amount of fat versus muscle in the body) and nutritional status in patients with End Stage Liver Disease (ESLD)

Detailed Description
-----------------
The aim of this study is to report the validity of mBIA to determine body composition changes pre and post LVP (Large Volume Paracentesis) 18 years of age or older Cirrhotic patients with refractory ascites requiring LVP (a treatment to remove large volumes of excess fluid from the abdominal cavity) End Stage Liver Disease

Official Title
-----------------
End Stage Liver Disease and Body Composition Assessment: Utilizing Bioelectric Impedance Analysis (BIA)

Conditions
-----------------
End Stage Liver Disease

Intervention / Treatment
-----------------
* Device: Bodystat Quadscan 4000
* Device: bodystat quadscan 400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ESLD requiring LVP. Age over 18. Ability to provide written informed consent. Exclusion Criteria: Organ retransplant candidates. Patient with use of any investigational agent within 30 days before LVP. Pregnant or lactating. Patients with non-bioprosthetic heart valves pacemakers, defibrillators, artificial joints, pins, plates, or other types of metal objects in the body. Amputations other than fingers or toes.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bodystat Quadscan 4000|device determining body composition and nutritional status|
|Device: bodystat quadscan 400|device determining body composition and nutritional status|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and utility of BIA in determining body composition and nutritional status using multi-frequency machines in patients with ESLD and ascites requiring LVP. |  | Before and after large volume paracentesis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the difference in BIA pre and post LVP to evaluate the impact of oncotic pressure in the assessment of total body composition. |  | Before and after large volume paracentis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioelectric impedance analysis, BIA, ESLD, LVP, Large volume paracentesis, Ascites, Liver, Hepatic
SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures. *Trademark

Detailed Description
-----------------
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.

Official Title
-----------------
A Prospective, Randomized, Exploratory Comparison of the SEMPERFLO* Pain Management System to a Commercially Available Pain Relief System in Subjects Undergoing Open Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia, Pain

Intervention / Treatment
-----------------
* Device: SEMPERFLO Pain Management System
* Device: ON-Q PainBuster Post-Op Pain Relief System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure Subject is 18 years or older Subject must be willing to participate in the study, and provide informed consent to participate. Exclusion Criteria: Subjects undergoing recurrent hernia repair; Subjects who plan to undergo another elective surgical procedure prior to the completion of this study; Subjects with known allergy to bupivacaine; Subjects with immunodeficiency diseases (including known HIV); Subjects with any findings identified by the surgeon that may preclude conduct of the study; Subjects who are known current alcohol and/or drug abusers;

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEMPERFLO Pain Management System<br> | Device: SEMPERFLO Pain Management System<br>* continuous infusion of 0.5% bupivacaine at 2mL per hour<br>* Other names: Pain management system;|
| Active Comparator: ON-Q PainBuster Post-Op Pain Relief System<br> | Device: ON-Q PainBuster Post-Op Pain Relief System<br>* continuous infusion of 0.5% bupivacaine at 2mL per hour<br>* Other names: Pain management system;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale |  | twenty-four hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic and non-narcotic analgesic usage |  | 24, 48, 72, 96 and 120 hours post- procedure | 
| Numeric pain scale scores at rest and with coughing |  | 24, 48, 72, 96, and 120 hours post-procedure |
Predicting the Outcome of Total Knee Arthroplasty and Spinal Surgeon

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to investigate the preoperative and operative factor of pain and functional outcome at one years following total knee arthroplasty and spinal surgeon.

Official Title
-----------------
Prospective Study of Risk Factors and Outcomes Following Total Knee Arthroplasty and Spinal Surgeon

Conditions
-----------------
Osteoarthritis;, Intervertebral Disc Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients have been waiting for surgery for treatment of osteoarthritis or disc degeneration disease. Must be between 18 and 65 years of age, of either sex. Must demonstrate willingness to participate in the study by signing the written informed consent. Exclusion Criteria: Patients with Mandatory spondylitis, infections, neoplasms, inflammation, deformities, or previous surgery of spine or knee. The patient is participating in an interventional clinical trial or has in an interventional clinical trial within 30 days prior to enrollment.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of functional score over time in the patients after operation |  | 3, 6, 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of quality of life score over time in the patients after operation |  | 3, 6, 12 monthes after surgery |