linjc16/ctgov huggingface dataset:
Brilliant Blue Versus Indocyanine Green

Study Overview
=================
Brief Summary
-----------------
A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.

Official Title
-----------------
A Randomized Study Comparing Brilliant Blue and Indocyanine Green as Intravitreal Dye in Macular Pucker and Macular Hole

Conditions
-----------------
Macular Pucker, Macular Hole, Vitreoretinal Surgery

Intervention / Treatment
-----------------
* Procedure: Indocyanine green
* Procedure: Brilliant blue arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 50 macular pucker or macular hole with subjective disturbances All phakic or pseudophakic patients far visual acuity better than 20/400 able to read, understand, and willing to sign the informed consent form Exclusion Criteria: any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker prior vitreoretinal surgery in the study eye

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Active Comparator: Indocyanine green arm<br> | Procedure: Indocyanine green<br>* Using indocyanine green as intraoperative dye<br>|
| Active Comparator: Brilliant blue<br> | Procedure: Brilliant blue arm<br>* Using brilliant blue as intraoperative dye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected far visual acuity (ETDRS) |  | 1 year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reading ability (Radner) |  | 1 Year | 
| Optical coherence tomography |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dye, internal limiting membrane, macular hole, macular pucker
Computed Tomography (CT) Guided Lung Biopsy With Plug

Study Overview
=================
Brief Summary
-----------------
Protocol Title: Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.

Detailed Description
-----------------
Protocol Summary: Prospective, randomized, controlled, unblinded, post-market, single-center clinical study Objectives: Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group). Primary Objective: Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy Secondary Objectives: Evaluate the rate of intra-procedural pneumothorax Evaluate the rate of post-procedural pneumothorax Evaluate cost associated with complications Evaluate the number of hospital admissions

Official Title
-----------------
Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy

Conditions
-----------------
Computed Tomography, Biopsy, Pneumothorax, Chest Tube, Plug

Intervention / Treatment
-----------------
* Device: The BioSentry Tract Sealant System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent prior to any study related procedure Male or female, aged ≥18 years or older Percutaneous transthoracic needle lung biopsy indicated Exclusion Criteria: There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Block randomized design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plug Arm<br>Participants randomized for plug arm will be treated with a plug after CT guided is conducted. | Device: The BioSentry Tract Sealant System<br>* The BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Seal™ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue.<br>|
| No Intervention: Non Plug arm<br>No Intervention, i.a. CT guided biopsy without plug. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the rate of chest tube | Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy | 2 years |
Effectiveness of Vibration and Standing Versus Standing Alone for the Treatment of Osteoporosis for People With Spinal Cord Injury.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if standing and/or standing with vibration works for the treatment of osteoporosis for people with a spinal cord injury.

Official Title
-----------------
Evaluation of Conventional and Innovative Standing Frame for the Treatment of Osteoporosis After Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury., Osteoporosis.

Intervention / Treatment
-----------------
* Device: vibration and passive standing versus passive standing alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Traumatic spinal cord injury of greater than 12 months. Osteopenia or osteoporosis of the hip. Exclusion Criteria: Pregnant or lactating females. Nonunion lower extremity fracture within the last 6 months. Bilateral hip or knee flexion contractures. Bilateral lower extremity total hip or knee replacement. Heterotopic ossification of the hip or knee. Concurrent treatment with a bisphosphonate.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: vibration and passive standing versus passive standing alone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density from baseline of the hip, distal femur and proximal tibia at 6-months and 12-months. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity (modified Ashworth). |  |  | 
| Quality of life. |  |  | 
| Frequency and severity of adverse events. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal Cord Injury., Osteoporosis., Standing., Vibration.
Clinical Trial to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
A randomized, single-blind, multi-center, Phase III clinical trial to evaluate the efficacy and safety of adhesion barrier Mediclore versus no treatment in patients with total thyroidectomy

Official Title
-----------------
A Randomized, Single-blind, Multi-center, Phase III Clinical Trail to Evaluate the Efficacy and Safety of Adhesion Barrier Mediclore Versus no Treatment in Patients With Total Thyroidectomy

Conditions
-----------------
Patients With Thyroidectomy (Scheduled)

Intervention / Treatment
-----------------
* Device: Mediclore® (adhesion barrier)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Male or female at least 20 years of age Patients without clinically significant lab Patients scheduled for thyroidectomy Exclusion Criteria: Another clinical trials within 1 month History of previous surgery on same position Anticoagulant, general steroids within a week from surgery Immunosuppression or autoimmune disease General or local infection Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies) Incompatible medications History of drug or alcohol abuse, mental disorder Pregnant or lactating women and fertile women who is not using proper contraceptive method History of esophagus diseases Keloid symptoms

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediclore®<br>adhesion barrier Mediclore 5cc, to apply medical device fully around thyroid gland following thyroidectomy | Device: Mediclore® (adhesion barrier)<br> <br> |
| No Intervention: No treatment<br>No treatment, standard treatment for thyroidectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesion incidence rate following 8 weeks |  | 8 weeks |
Different Surgical Techniques for Pterygium Surgery

Study Overview
=================
Brief Summary
-----------------
A study to research the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium.

Detailed Description
-----------------
To analyze the epidemiological profile of patients who were operated of pterygium in Eyes Institute of Goiânia, analyze the post-operative results according to the chosen surgical technique and evaluate the refractive changes before and after the excision of pterygium.

Official Title
-----------------
Epidemiological Profile and Comparison Between Different Surgical Techniques for Pterygium Surgery

Conditions
-----------------
Pterygium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were underwent the pterygium surgery during the period between from February 2013 to August 2013 Exclusion Criteria: Patients with mature cataract

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| Pterygium<br>Patients who were operated of pterygium | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive pre-operative | Refractive before the excision of pterygium | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive post-operative | Refractive after the excision of pterygium | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pterygium surgery, refractive changes, surgical technique
Evaluation of the Periotest Method in Dental Traumatology

Study Overview
=================
Brief Summary
-----------------
Background/Aims: The Periotest® method represents a technique for objective tooth mobility assessment. The aims of this study were: 1. receiving information about normal Periotest® values in vertical and horizontal dimension on periodontally healthy teeth for individuals aged 20-35, 2. investigating the reliability of the Periotest® method in terms of intra-serial and inter-serial reproducibility before splinting and with an applied dental trauma splint, 3. evaluating the splint effect of two different wire-composite splints in vivo. Materials and Methods: On periodontally healthy dental students (n=33; mean age 24.7 years) Periotest® values were measured on reproducible measuring points, in vertical and horizontal dimension and before splinting and after splint insertion. Three readings were taken per serial to observe the intra-serial reproducibility, and for testing inter-serial reproducibility three serials were measured (Friedman-test; P ≤ 0.001). Two different wire-composite-splints (1 = Dentaflex 0.45 mm, 2 = Strengtheners 0.8x1.8) were inserted, the Periotest® values were measured and the splint effects were calculated and compared (Whitney-Mann-U-test; P ≤ 0.001).

Official Title
-----------------
Evaluation of the Periotest Method as a Tool for Tooth Mobility Monitoring and Splint Rigidity Assessment in Dental Traumatology

Conditions
-----------------
Dental Trauma

Intervention / Treatment
-----------------
* Device: Wire Composite Splint (Dentaflex 0.45 mm)
* Device: Wire Composite Splint (Denture Strengtheners)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 19-36 healthy upper front teeth Exclusion Criteria: periodontal disease orthodontic treatment during the investigation period history of dental trauma fillings or restorations on upper front teeth endodontically treated teeth

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 36 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no periodontal disease<br>33 dental students (13 male, 20 female) with a mean age of 24.7 years (min. 19.8; max. 36.5) with no periodontal disease or dental trauma | Device: Wire Composite Splint (Dentaflex 0.45 mm)<br>* Wire-Composite-Splint: Dentaflex 0.45 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow (IvoclarVivadent, Schaadn, Liechtenstein) to the teeth<br>Device: Wire Composite Splint (Denture Strengtheners)<br>* Wire-Composite-Splint: Denture Strengtheners 0.8x1.8 mm (Dentaurum, Pforzheim, Germany) attached with Tetric flow to the teeth<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
-----------------
Tooth mobility assessment, Splinting, Splint Rigidity
Schizophrenic Patients Taking Part in Integrated Care Program

Study Overview
=================
Brief Summary
-----------------
Purpose of this non-interventional study (NIS) is to assess the effect of the participation in an integrated care program on treatment outcomes in patients treated with Seroquel for schizophrenia.

Official Title
-----------------
Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Non-interventional Study

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Schizophreni-form Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients suffering from schizophrenia, schizoaffective disorder, schizophreni-form disorder, delusional disorder or psychotic disorder not otherwise specified Age 18 - 65 years Current stable treatment with Seroquel according to SmPC since at least 2 months Given consent to take part in an integrated care program prior to study startWritten informed consent to take part in this NIS Exclusion Criteria: Presence of any contraindication as described in the SmPC Cancellation of participation in the integrated care program

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All<br>Schizophrenic outpatients who are treated with Seroquel IR and who are additionally intended to start with an integrated care program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Well-Being measured via SWN patient questionnaire |  | 6 month period of observation,4 assessments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life and patient's satisfaction measured by Q-LES-Q-18 and CSQ-8 |  | 6 month period of observation, 1 assessment at end of NIS | 
| Symptomatic and functional outcome measured by CGI-S, PANSS-8, GAF, EQ-5D and VOI |  | 6 month period of observation, 4 assesments | 
| Compliance and health economic aspects measured by MARS, days of hospitalization, productivity loss |  | 6 month period of observation, 4 assesments | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Integrated care program, Seroquel
The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.

Study Overview
=================
Brief Summary
-----------------
This is a prospective study. Patients' cohort is composed of 70 consecutive post joint replacement and post tibial ORIF patients, referred by their orthopedic surgeon to the Nuclear Medicine institute of Tel Aviv Sourasky Medical Center in the diagnostic work up of post operative bone infection and or mechanical loosening. The proposed study will be presented to the ethical committee of the medical center and will be started once approved.

Official Title
-----------------
The Role of NM/CT 870 DR Camera in the Diagnosis of Joint Prosthesis and Tibial Open Reduction and Internal Fixation (ORIF) Complications.

Conditions
-----------------
Bone Infection

Intervention / Treatment
-----------------
* Other: Bone Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening. Exclusion Criteria: Patients younger than 18 years; Shorter than 3 month surgical intervention at the suspected area; Newly diagnosed (<3 months) fractures around the prosthesis; Pathological fractures (e.g. Metastatic).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone inaction patients<br>Three months or more post joint replacement, or post tibial ORIF, or last surgical intervention adult patients suspected of bone infection and or mechanical loosening. | Other: Bone Scan<br>* Bone Scan: three-phase planar Bone Scan and a SPECT/CT [perfusion, blood pool and SPECT/CT of the relevant region of interest (ROI), and a whole-body planar late bone scan].<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the role of NM imaging in the diagnosis work up of joint prosthesis and tibial ORIF complications by using GE NM/CT 870 DR camera and its accompanied tools.. |  | 1 year |
The Community United to Challenge Asthma

Study Overview
=================
Brief Summary
-----------------
This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education in high-risk Puerto Rican children in elementary school. The primary outcomes are asthma medication adherence and trigger reduction.

Official Title
-----------------
A Community-Academic Partnership to Improve Asthma Management in Latino Children

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: community health worker
* Behavioral: mailed information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Puerto Rican In elementary school Diagnosed with asthma Exclusion Criteria: Not in school Mild intermittent asthma Well controlled asthma

Ages Eligible for Study
-----------------
Minimum Age: 5 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mailed information<br>information on asthma is mailed to the home on the same schedule as the other arm | Behavioral: mailed information<br>* information on asthma is mailed to the home on the same schedule as the other arm<br>|
| Experimental: community health worker<br>community health worker provides home visits for education | Behavioral: community health worker<br>* community health worker provides home visits for education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medication adherence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trigger reduction |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric asthma