linjc16/ctgov huggingface dataset:
Clinical Comparison of Different Flowable Resin Composites

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate a self-adhesive flowable resin composite, a flowable resin composite with high viscosity and a conventional flowable resin composite in combination with a universal adhesive using two different application modes. All patients will receive at least 4 occlusal restorations. Cavities will be divided into four groups according to restorative systems used: Constic (a self-adhering flowable composite), G-ænial Universal Flo (a highly filled flowable composite), Tetric N-Flow (self-etch) (a conventional flowable composite), Tetrin N-Flow (etch&rinse).

Official Title
-----------------
Clinical Comparison of Different Flowable Resin Composites

Conditions
-----------------
Tooth Diseases

Intervention / Treatment
-----------------
* Device: Constic
* Device: G-ænial Universal Flo
* Device: Tetric N-Flow (self-etch)
* Device: Tetric N-Flow (etch&rinse)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having no medical or behavioral problems preventing then from attending review visits absence of previously placed restorations having antagonist teeth Exclusion Criteria: poor gingival health uncontrolled, rampant caries bruxism removable partial dentures xerostomia

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Constic<br>Constic (DMG, Hamburg, Germany) | Device: Constic<br>* Flowable resin composite<br>|
| Experimental: G-ænial Universal Flo<br>G-ænial Universal Flo (GC Corporation, Tokyo, Japan) in combination with G-Premio Bond (self-etch mode) | Device: G-ænial Universal Flo<br>* Flowable resin composite<br>|
| Experimental: Tetric N-Flow (self-etch)<br>Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (self-etch mode) | Device: Tetric N-Flow (self-etch)<br>* Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)<br>|
| Experimental: Tetric N-Flow (etch&rinse)<br>Tetric N-Flow (Ivoclar Vivadent, Schaan, Liechtenstein) in combination with Tetric N-Bond Universal (etch&rinse mode) | Device: Tetric N-Flow (etch&rinse)<br>* Tetric N-Flow (Tetric N-Bond Universal, etch&rinse mode)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performances of different flowable resin composite | Two year results according to USPHS criteria | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flowable resin composite, occlusal
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and Haemophilus influenza type b.

Detailed Description
-----------------
The duration of treatment is 65 weeks.

Official Title
-----------------
A Registration Study of the Safety, Tolerability, and Immunogenicity of V441 in Healthy Infants in Taiwan

Conditions
-----------------
Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis

Intervention / Treatment
-----------------
* Biological: V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infant who received Hepatitis B vaccine within 5 days of birth and whose mother is negative to Hepatitis B surface antigen Exclusion Criteria: Problems with immune system Recent illness with fever

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks
Maximum Age: 8 Weeks

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and immune responses adequate to be protective against diphtheria, tetanus, pertussis, polio, Haemophilus Influenzae Type B, and Hepatitis B. |  |  |
The Medacta International SMS Post-Marketing Surveillance Study

Study Overview
=================
Brief Summary
-----------------
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.

Official Title
-----------------
The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study

Conditions
-----------------
Avascular Necrosis of the Femoral Head, Arthrosis, Traumatic Arthritis, Rheumatoid Polyarthritis, Congenital Hip Dysplasia

Intervention / Treatment
-----------------
* Device: SMS femoral stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head. In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery. Scheduled for a primary total hip replacement. Exclusion Criteria: Active infection Pregnancy Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews Grossly distorted anatomy (surgeon's discretion) Osteomalacia where uncemented implant fixation is contraindicated Active rheumatoid arthritis. Osteoporosis Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated Muscular atrophy or neuromuscular disease Allergy to implant material Any patient who cannot or will not provide informed consent for participation in the study Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SMS femoral stem|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survivorship of the Medacta SMS femoral stem |  | 10-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical performance | Harris Hip Score | 3, 5, 7 and 10 years | 
| radiographic performance | presence of radiolucencies | 3, 5, 7 and 10 years | 
| Evaluate the patient satisfaction | Oxford score | 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years | 
| Evaluate the quality of life | EQ-5D | 6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years | 
| pattern of bone remodeling | Dual Energy X ray Absorptiometry (DEXA) | 6 weeks, 6 months, 1 year | 
| stem migration | Radiostereometric Analysis (RSA) | 6 weeks, 6 months, 1 and 2 years | 
| Adverse events | record of adverse event | up to 10 years |
Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.

Official Title
-----------------
Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: remote magnetic catheter navigation
* Procedure: cavotricuspid isthmus ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECG documentation of at least 1 episode of typical atrial flutter Exclusion Criteria: Prior right atrial ablation Ferromagnetic implants that may interfere with the magnetic navigation system Pregnancy

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 |
| --- | --- |
| Other: 1<br>conventional ablation with manual catheter navigation | Procedure: cavotricuspid isthmus ablation<br>* conventional (manual) approach<br>|
| Active Comparator: 2<br>ablation with remote magnetic catheter navigation | Device: remote magnetic catheter navigation<br>* use of the Stereotaxis system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ablation duration and fluoroscopy time |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total procedure duration, success, ablation characteristics, flutter recurrence, complications |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial flutter, ablation, navigation
Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The hypotheses of this study is that the use of the instrument Harmonic Scalpel (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

Detailed Description
-----------------
Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent. After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data. A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above. The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.

Official Title
-----------------
Randomized Controlled Trial Comparing Traditional Vaginal Hysterectomy to Harmonic Scalpel Hysterectomy

Conditions
-----------------
Vaginal Hysterectomy

Intervention / Treatment
-----------------
* Procedure: Performing Vaginal hysterectomy with Harmonic Scalpel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient already on waitlist requiring vaginal hysterectomy Exclusion Criteria: No patient consent
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

| Intervention/Treatment |
| --- |
|Procedure: Performing Vaginal hysterectomy with Harmonic Scalpel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  |  | 
| Time to discharge |  |  | 
| Blood loss |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost |  |  | 
| Complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaginal, Hysterectomy, Harmonic, Ligasure, Sutures, Modern, Patients undergoing vaginal hysterectomy for various reasons
Dietary Factors and Racial Disparities in Prostate Cancer Aggressiveness

Study Overview
=================
Brief Summary
-----------------
The North Carolina-Louisiana Prostate Cancer Project is a population-based case-only study of over 2,000 men newly diagnosed with prostate cancer designed to address racial differences in prostate cancer aggressiveness and survival through a comprehensive evaluation of social, individual, and tumor level influences on prostate cancer aggressiveness. Project 3 specifically aims to examine nutritional modulation of prostate cancer aggressiveness using dietary assessment and biomarker-based data on dietary factors.

Detailed Description
-----------------
A total of 2,258 (1,130 African Americans and 1128 European Americans) men newly diagnosed with prostate cancer in North Carolina and Louisiana were enrolled into the study between 2004 and 2009. Participants signed informed consent and were interviewed by a trained nurse who collected information on demographics, occupation, family history, health status, health care, prostate cancer diagnosis and screening history, medication use, anthropometrics, lifestyle factors (e.g., physical activity, smoking), and diet and supplement use. Research subjects were asked to recall their diet in the year prior to prostate cancer diagnosis via a modified version of the National Cancer Institute Diet History Questionnaire. Vitamin and supplement use in the year prior to prostate cancer diagnosis was assessed via a validated questionnaire, and current use was assessed by bottle label inventory. Blood, urine, and adipose tissue samples were collected.

Official Title
-----------------
The North Carolina-Louisiana Prostate Cancer Project, Project 3 Ancillary Study

Conditions
-----------------
Prostatic Neoplasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first diagnosis of histologically confirmed adenocarcinoma of the prostate 40-79 years old at diagnosis, can complete the study interview in English, do not live in an institution (nursing home), are not cognitively impaired or in a severely debilitated physical state, are not under the influence of alcohol, severely medicated, or apparently psychotic at the time of the interview. must self-identify as at least part African American/Black or Caucasian American/White/European American. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High aggressive prostate cancer | Gleason score>=8, or PSA>20ng/ml, or Gleason score>7 and clinical stage T3-T4 | Baseline (cross-sectional study) |
Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

Study Overview
=================
Brief Summary
-----------------
To examine, through retrospective and prospective chart review, the difference in pain and mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain scale and Roland Morris Disability Questionnaire (RMDQ). CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.

Detailed Description
-----------------
The purpose of the study is to report the use of CT fluoroscopy guidance during the performance of percutaneous sacroplasty. In addition, clinical results will be reported with the Roland Morris Disability Questionnaire(RMDQ)pre and post procedure, demonstrating the utility of the RMDQ in assessing improvement in patients pain, mobility and ability to perform activities of daily living.

Official Title
-----------------
Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

Conditions
-----------------
Sacro-iliac Insufficiency Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 18 years of age and treated with or about to be treated with percutaneous CT fluoro-guided sacroplasty, regardless of gender or ethnicity. Exclusion Criteria: less than 18 years old pregnancy inability to complete forms and surveys

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 |
| --- | --- | --- |
| Reduction of pain and improved mobility in patients post percutaneous sacroplasty effectively assessed using the VAS pain scale and RMDQ both pre and post procedure. | The average pre-treatment VAS score was significantly improved after sacroplasty in patients with sacral insufficiency fractures. | 2008-2012 |
Proteomics in Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.

Detailed Description
-----------------
The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital and blood samples from 50 healthy blood donors. The blood samples from SCLC patients will be collected before chemotherapy with Carboplatin and Etoposide and after 2 cycles of chemotherapy. Imaging will be performed at the Dept. of Radiology, Aalborg University Hospital before chemotherapy and after 3 cycles of the treatment.

Official Title
-----------------
Circulating Metabolites and Tumor-derived Extravesicular Proteins in Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written and signed informed consent Histopathologically and/or cytologically newly-diagnosed SCLC Measurable disease on CT scans Eligibility to receive standard chemotherapy consisting of carboplatin and etoposide Exclusion Criteria: Active biopsy-verified second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ Prior treatment for any malignant diseases other than non-melanoma skin cancer and cervical carcinoma in situ Concomitant anticoagulation treatment (acetylsalicylic acid and clopidogrel are allowed) Treatment with any other investigational agent

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 |
| --- | --- | --- |
| Identification and validation of protein biomarkers | For identification and validation of protein biomarkers both untargeted and targeted proteomics will be performed, including a discovery-based bottom-up mass spectrometry approach and label-free Quantification Nano Liquid Chromatography Tandem Mass Spectrometry (LFQ nLC-MS/MS), enzyme-linked immunosorbent assay (ELISA)-based proteomics, and Western Blot analyses. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Proteomics, Biomarkers
Effect of Deproteinization on the Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.

Official Title
-----------------
Effect of 5,25% Sodium Hypochlorite Enamel Deproteinization on the Initial Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets Bonded With a Self-etching Primer: An In Vitro Study on Human Bicuspids.

Conditions
-----------------
Orthodontic Appliance Complication

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - All patient with orthodontic treatment involving bicupids extractions Exclusion criteria: - Patients with damaged teeth

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Number of resistance to tearing of orthodontic brackets stuck to extracted premolars | Number of resistance to tearing of orthodontic brackets stuck to extracted premolars | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self-etching bracket, glue penetration, orthodontic brackets