linjc16/ctgov huggingface dataset:
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head & Neck surgery.

Official Title
-----------------
Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery

Conditions
-----------------
Parotid Diseases

Intervention / Treatment
-----------------
* Procedure: Parotidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an indication for surgical intervention for a parotidectomy. ECOG status ≤ 2. Life expectancy > 3 months. Age ≥ 18 years old. Able to provide written informed consent and EU Data Protection Directive forms prior to admission to this study. Willingness to meet all of the expected requirements of this clinical protocol. Exclusion Criteria: Age < 18 years old. Pregnant or breastfeeding. Vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.). Concomitant treatments that would affect clotting, post-operative healing, increased chances of infection. Previous radiation treatment Previous head or neck 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parotidectomy<br>Patients with an indication for surgical intervention for a parotidectomy. | Procedure: Parotidectomy<br>* Surgical Intervention with the FMwand Surgical System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility | Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System. | 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative drainiage | Evaluation of Post-operative Drainage | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | 
| Swelling of surgical wound | Evaluation of surgical wound appearance based on swelling | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | 
| Necrosis of surgical margins | Serosity and necrosis of margins | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days | 
| Length of hospital stay | Number of days (post-operative) of hospital stay | Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days |
Fibroscan Predicts Complications After Hepatectomy

Study Overview
=================
Brief Summary
-----------------
Most of the postoperative complications that may occur after hepatectomy are related to the underlying liver background, and the common preoperative tests do not completely predict such complications. Transient elastography by Fibroscan is used to calculate the stiffness and the steatosis of the liver, and it may be also used to predict postoperative complications after hepatectomy

Detailed Description
-----------------
A prospective cohort study on consecutive patients scheduled for hepatectomy was planned. Fibroscan was performed during the preoperative workup. Accuracy of the liver stiffness and steatosis measured by Fibroscan in predicting the presence of cirrhosis, of steatosis, and the development of postoperative complications was assessed by ROC curve, and multivariate analysis.

Official Title
-----------------
Role of Fibroscan in Predicting Complications After Hepatectomy

Conditions
-----------------
Liver Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary and secondary tumors scheduled for hepatectomy at our Unit Written consent to get the Fibroscan during the preoperative workup Exclusion Criteria: Refute to get the Fibroscan Loss of data

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 |
| --- | --- | --- |
| Accuracy of Fibroscan in predicting complication after hepatectomy | Calculation of the accuracy of the liver stiffness and steatosis measured with the Fibroscan in predicting complications after hepatectomy. The values of the stiffness and steatosis will be correlated with the number of complications | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complications after hepatectomy
Comparing Fixed-bearing Versus Mobile-bearing Prosthesis in Total Knee Arthroplasty: A Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Detailed Description
-----------------
Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

Official Title
-----------------
Study of Prosthesis in Total Knee Arthroplasty

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

Intervention / Treatment
-----------------
* Device: fixed-bearing (P.F.C.® Sigma)
* Device: mobile-bearing (P.F.C.® Sigma)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with expected primary total knee arthroplasty Exclusion Criteria: Mediolateral instability Infective arthritis Severe deformity Revision
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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: fixed-bearing<br>fixed-bearing device is a kind of prosthesis | Device: fixed-bearing (P.F.C.® Sigma)<br>* P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK<br>|
| Other: mobile-bearing<br>mobile-bearing device is a kind of prosthesis | Device: mobile-bearing (P.F.C.® Sigma)<br>* P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Scoring | was used for evaluating the function of the knee and high scores indicated better knee function | five years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain was evaluated with a Visual Analogue Scale (VAS) with scores ranging from zero to 10ten (0 for no pain and 10 for intolerable pain). | five years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fixed-bearing, Total knee arthroplasty, Mobile-bearing
RAM Cannula VS Short Nasal Prongs for Delivering NIPPV in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Randomized control trial, Ram cannula VS short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants

Detailed Description
-----------------
Randomized control trial comparing Ram cannula to the regular, more investigated short nasal prongs for delivering Non Invasive Positive Pressure Ventilation (NIPPV) for preterm infants with respiratory distress.

Official Title
-----------------
RAM Cannula for Delivering Nasal Intermittent Positive Pressure Ventilation (NIPPV) in Preterm Infants: Non Inferiority Randomized Control Trial

Conditions
-----------------
Respiratory Distress Syndrome, Newborn, Noninvasive Ventilation, Infant, Premature, Intubation, Intratracheal

Intervention / Treatment
-----------------
* Device: Ram cannula
* Device: Short nasal prongs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age 24-33.6 Physician decision on the need for non invasive ventilation parental consent Exclusion Criteria: Pneumothorax before recruitment Significant congenital heart disease or chromosomal disorder

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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
Interventional Model Description: Non Inferiority Randomized Control Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ram cannula<br>NIPPV VIA Ram cannula | Device: Ram cannula<br>* Ventilatory support for preterm infants using Ram cannula<br>|
| Active Comparator: Short nasal prongs<br>NIPPV VIA short nasal prongs | Device: Short nasal prongs<br>* Ventilatory support for preterm infants using short nasal prongs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation | The need for intubation | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasal trauma | nasal trauma | during NIPPV procedure |
SEPA III: The Effectiveness Trial

Study Overview
=================
Brief Summary
-----------------
The study evaluates the effectiveness of SEPA (Salud, Educacion, Prevencion y Autocuidado; Health, Education, Prevention and Self-Care) to increase HIV prevention behaviors and to reduce the incidence of STIs for Hispanic women when delivered in a real-world setting by community agency personnel. The study recruits Hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either SEPA or a Wait-List Control condition.

Official Title
-----------------
SEPA III: The Effectiveness Trial

Conditions
-----------------
HIV Prevention

Intervention / Treatment
-----------------
* Behavioral: SEPA III


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hispanic Women, 18 to 50 years old, Sexually active in the past three months Exclusion Criteria: Non-Hispanic, younger than 18, older than 50, not sexually active

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

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Wait List Control<br> | |
| Experimental: SEPA III Intervention<br>SEPA brings together two important theoretical perspectives that will be effective and sustainable for HIV/AIDS prevention among Hispanic women in an inner city environment. The content and learning strategies of SEPA are based on the social cognitive theory and of HIV/AIDS prevention that prior research has shown to be the most effective in increasing HIV/AIDS prevention behaviors, modified to take into account the special needs of Hispanic women related to gender inequality and cultural values and practices. SEPA's conceptual framework integrates the Social Cognitive Model of behavioral change with Freire's Pedagogy of the Oppressed that guides the delivery and contextual tailoring. | Behavioral: SEPA III<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condom Use |  | 1 year |
Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia

Study Overview
=================
Brief Summary
-----------------
Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device

Official Title
-----------------
Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia

Conditions
-----------------
Coccyx Injury

Intervention / Treatment
-----------------
* Device: ESWT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of coccydynia by clinical examination and X-ray imaging. be aged ≥18 at the time of diagnosis be give informed consent Exclusion Criteria: Malignancy Those who have received ESWT treatment before Pediatric patients Patients with infection.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Focus extracorporeal shock wave therapy<br>A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area | Device: ESWT<br>* Extracorporeal Shock-wave Therapy<br>|
| Active Comparator: Radial extracorporeal shock wave therapy<br>A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area | Device: ESWT<br>* Extracorporeal Shock-wave Therapy<br>|
| Sham Comparator: Sham extracorporeal shock wave therapy<br>A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area | Device: ESWT<br>* Extracorporeal Shock-wave Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | pain evaluation, higher scores mean worse outcome. | 1 minute | 
| Oswestry Low Back Pain Disability Questionnaire | higher scores mean better outcome. | 5 minutes |
Satiety Effects of Pulses Compared to Matched Protein Smoothie

Study Overview
=================
Brief Summary
-----------------
The satiety effects of pulses compared to a matched smoothie will be measured.

Detailed Description
-----------------
The investigators will compare satiety and food intake after consumption of purses or a calorie/protein matched smoothie

Official Title
-----------------
Satiety Effects of Pulses Compared to Matched Protein Smoothie

Conditions
-----------------
Food Selection

Intervention / Treatment
-----------------
* Dietary Supplement: purses
* Dietary Supplement: a calorie/protein matched smoothie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, normal body weight, Exclusion Criteria: smoker, restrained eating habits, recent weight change, history of disease, vegetarian, do not normally eat breakfast or lunch, are pregnant or lactating, have irregular menstrual cycles

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: purses or a calorie/protein matched smoothie<br> | Dietary Supplement: purses<br>* food intake<br>Dietary Supplement: a calorie/protein matched smoothie<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety |  | 120 minutes |
Adult Weight, Genetics and Lifestyle Factors

Study Overview
=================
Brief Summary
-----------------
Childhood obesity leads to adulthood obesity, demonstrated in many retrospective and longitudinal studies. Genetics as a predictor of obesity is less established. Morandi et al, (2012) assessed whether lifestyle and genetic factors can be used to predict childhood obesity, concluding that genetics had minimal predictive effect. More recently Seyednasrollah, (2017) demonstrated that genetic information, when alongside clinical factors for cardiovascular disease, increased the predictive accuracy of obesity risk in adults. This study aims to investigate if known lifestyle and genetic risk factors are associated with BMI and if they can be used as predictors of overweight/obesity in adults.

Official Title
-----------------
The Influence of Nutrition, Childhood and Adult Lifestyle Factors and Genetic Predisposition on Body Mass Index

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

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: European Citizen. Aged between 18-65 years. Female. Caucasian Exclusion Criteria: Currently following a diet or weight loss plan or have not been for over 6 months of the previous year. Suffering from diabetes (type I or II). Cancer, or have had cancer in the past.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Whole Sample<br>Female, caucasians, aged 18-65 years | Other: No intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | September - November 2018 |
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)

Study Overview
=================
Brief Summary
-----------------
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.

Official Title
-----------------
A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck

Conditions
-----------------
Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmation of evidence of squamous cell carcinoma of the head and neck. Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy. Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy. Exclusion Criteria: Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors. Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy. Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products.

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

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Drug: methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare ZD1839 versus methotrexate in overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Squamous cell carcinoma of the head and neck
Study of Genetic Polymorphisms in Thai HIV-1 Infected Patients on SQV/r

Study Overview
=================
Brief Summary
-----------------
Study of genetic polymorphisms of CYP #A and MDR-1 genes in Thai HIV-1 infected patients on saquinavir/ritonavir.

Detailed Description
-----------------
Genetic polymorphisms will be investigated by polymerase-chain reaction (PCR) and drug levels of saquinavir will be determined by high phase liquid chromatography with UV-detected (HPLC).

Official Title
-----------------
Study of Genetic Polymorphisms of CYP 3A and MDR-1 Genes in Thai HIV-1 Infected Patients on Saquinavir/Ritonavir

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Genetic: identify genetic polymorphism in Thai HIV infected


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected persons who have been enrolled in the Staccato study On low-dose ritonavir boosted saquinavir at the time blood samples are collected Exclusion Criteria: Inability to understand the nature and extent of the study and the procedures required

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>patients involved in structured interruption therapy | Genetic: identify genetic polymorphism in Thai HIV infected<br>* Gene sequencing of Cyp450 metabolic pathway<br>|

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
-----------------
genetic polymorphism, CYP 3A, MDR-1, Thai, HIV, Treatment Experienced