linjc16/ctgov huggingface dataset:
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.

Official Title
-----------------
A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

Conditions
-----------------
Non-infectious Uveitis

Intervention / Treatment
-----------------
* Drug: Fluocinolone Acetonide 0.59mg
* Drug: Fluocinolone Acetonide 2.1mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent, Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study, Had clinically 'quiet' eyes at surgery. Exclusion Criteria: Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Experimental: Fluocinolone Acetonide 0.59mg<br>Fluocinolone acetonide intravitreal implant 0.59mg | Drug: Fluocinolone Acetonide 0.59mg<br>* Fluocinolone Acetonide Intravitreal Implant 0.59 mg<br>|
| Experimental: Fluocinolone Acetonide 2.1mg<br>Fluocinolone acetonide intravitreal implant 2.1mg | Drug: Fluocinolone Acetonide 2.1mg<br>* Fluocinolone Acetonide Intravitreal Implant 2.1 mg<br>|
| No Intervention: No Intervention<br>Fellow eye | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye. |  | 1 year pre-implantation; 3 years post-implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys. |  | 1 year pre-implantation; 3 years post-implantation |
Application of Computer-assisted Navigation in Total Knee Arthroplasty: A Randomized Pair-matched Double-blind Trial

Study Overview
=================
Brief Summary
-----------------
Objective: The purpose of this study is to evaluate the application of computer-assisted navigation in Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA. Methods: Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system (BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and the conventional TKA were separately performed on two knee joints. The operative method and order of the operations were decided on a randomized basis. All the patients and doctors conducting follow-up study and performing imaging measurement were blind to selection of the operation. Student t test was used for statistical analysis. hypothesis: computer-assisted navigation system can significantly improve the accuracy of tibial and femoral cuts on coronal and sagittal planes.

Conditions
-----------------
Knee Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: plan for simultaneous bilateral TKA. Exclusion Criteria: plan for unilateral TKA.
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041

Study Overview
=================
Brief Summary
-----------------
A phase1 study to demonstrate [68Ga]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.

Official Title
-----------------
A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT

Conditions
-----------------
Prostate Cancer, Bone Metastases

Intervention / Treatment
-----------------
* Drug: [68Ga]P15-041


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical [99mTc]MDP scan Exclusion Criteria: Estimated creatinine clearance (GFR) < 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic imaging group<br>Dynamic imaging of suspected bone metastases with the investigation drug [68Ga]P15-041 | Drug: [68Ga]P15-041<br>* Imaging by Positron Emission Tomography after injection of [68Ga]P15-041<br>|
| Experimental: Whole body dosimetry group<br>Determination of human dosimetry of the investigation drug [68Ga]P15-041 | Drug: [68Ga]P15-041<br>* Imaging by Positron Emission Tomography after injection of [68Ga]P15-041<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of uptake of [68Ga]P15-041 in bone metastases | kinetics of [68Ga]P15-041 uptake in known or suspected bone metastases in prostate cancer | 60 minutes post injection | 
| Time course of whole body distribution of [68Ga]P15-041 | whole body distribution of [68Ga]P15-041 used for human dosimetry determination | 3 hours post injection |
International T1 Multicentre CMR Outcome Study

Study Overview
=================
Brief Summary
-----------------
Myocardial fibrosis is the fundamental substrate for the development of heart failure. Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis based on late gadolinium enhancement (LGE) and T1 mapping. Patients: Prospective longitudinal observational multicenter study of consecutive patients with suspected or known non-ischemic cardiomyopathy. Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume fraction (ECV) and LGE. Primary endpoints: all cause and cardiovascular mortality. Secondary endpoints: arrhythmic composite and HF composite endpoints.

Official Title
-----------------
International T1 Multicentre CMR Study

Conditions
-----------------
Cardiomyopathy, Heart Failure, Coronary Artery Disease, Chronic Kidney Diseases, Inflammation, Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults > 18 years of age clinical indication for CMR able to provide informed consent Exclusion criteria: contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or objects

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 |
| --- | --- | --- |
| Survival | number of deaths | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Arrhythmia | number of fatal or aborted sudden cardiac death events (including a documented appropriate shock from ICD) | 1 year | 
| Rate of HF events | Number of HF death and unplanned HF hospitalization | 1 year | 
| Rate of deaths due to cardiovascular causes | Number of composite of sudden cardiac death (SCD), death from HF, death from stroke or thromboembolic event | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T1 mapping, CMR, Outcome, multicenter
Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment

Study Overview
=================
Brief Summary
-----------------
Clinical and microbiological evaluation of Calcium silicate versus Calcium hydroxide in two-step indirect pulp treatment: Randomized clinical trial

Official Title
-----------------
Clinical and Microbiological Evaluation of Calcium Silicate Versus Calcium Hydroxide in Two-step Indirect Pulp Treatment: Randomized Clinical Trial

Conditions
-----------------
Deep Caries

Intervention / Treatment
-----------------
* Other: Calcium hydroxide
* Other: Calcium silicate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 years. Males or females. Co-operative patients approving to participate in the trial. Exclusion Criteria: Patients younger than 19 years old or older than 50 years old. Disabilities. Systemic diseases or severe medically compromised. Lack of compliance.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium silicate<br>intervention | Other: Calcium silicate<br>* Pulp capping material<br>* Other names: Theracal;|
| Active Comparator: Calcium Hydroxide<br>Comparator | Other: Calcium hydroxide<br>* Pulp capping material<br>* Other names: Dycal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain: VAS | post operative pain after 6 month from material application will be measured by visual analogue scale (VAS)with score from 0 to 10 in which 0 means no pain and 10 means the worst pain | 6 month |
Establishing Safe Drainage Limits for Pleural Chest Tube Removal.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.

Detailed Description
-----------------
Measurement of pleural fluid drainage in chest tubes of trauma patients.

Official Title
-----------------
Defining the Threshold for Safe Chest Tube Removal.

Conditions
-----------------
Thoracic Surgery, Thoracic Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of at least one chest tube No air leak present Fluid is not infected Pleural drainage of fluid was an indication for placement of the chest tube Patient is post-thoracic surgery Patient is post-thoracic trauma Informed consent obtained Exclusion Criteria: Presence of air leak Infected pleural fluid Active intra-thoracic bleeding Thoracic empyema Non-removal of chest tube (i.e.: expired) Pregnancy Less than 18 years of age Unable to obtain informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients that have their chest tube removed when drainage is 400mL or less in 24 hours. | |
| Group B.<br>Patients that have their chest tube removed when drainage is 200mL or less in 24 hours. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeat chest tube insertion within 30 days |  | two years | 
| Thoracotomy on affected side within 30 days |  | Two years |
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.

Official Title
-----------------
Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Conditions
-----------------
Gastrointestinal Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue. Infant is not receiving steroids. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) Exclusion Criteria: Participation in another study that has not been approved as a concomitant study by AN

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 180 Days

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 |
| --- | --- | --- |
| Weight | Measured in Kg | Baseline to Study Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula Intake | Parent completed diary | Baseline to Study Day 30 |
To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops

Study Overview
=================
Brief Summary
-----------------
This is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane
* Other: Refresh Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question. A sodium fluorescein corneal staining sum of ≥ 3 in either eye. A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart. Exclusion Criteria: A history or evidence of ocular or intraocular surgery in either eye within the past 6 months. Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study. A history of intolerance or hypersensitivity to any component of the study medications.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br>Systane Lubricant Eye Drops | Other: Systane<br>* Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)<br>|
| Experimental: Refresh Tears<br>Refresh Tears Lubricant Eye Drops | Other: Refresh Tears<br>* Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye. | This is a descriptive study in which changes from baseline in Tear Break up Time, corneal staining, and the Ocular Symptoms Questionnaire will be evaluated by treatment group at every visit. The outcome of the IDEEL questionnaire at Visit 3 will be compared to Visit 1 by treatment group; the results of treatment satisfaction questionnaires will be tabulated by treatment at Visit 3. | Baseline to visit 3 (Day 42) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systane, Refresh Tears, Dry Eye, Moderate to Severe Dry Eye
The Clinical Study of Acute Pancreatitis Treated by TongFuSan

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether TongFuSan is effective in the treatment of acute pancreatitis with gastrointestinal dysfunction.

Detailed Description
-----------------
Patient who is diagnosed with acute pancreatitis(AP) should be included. Patients will be divided into two groups as random number table: control group(A) and experimental group(B). Group A will be given Mosapride po,and group B will be given TongFusan except for basic treatments of AP. Same investigator will write the case report form. Investigator will collect the patients' blood in three points: on admission, the third day and the seventh day. Otherwise, we need write down patients' clinical manifestation,Traditional Chinese Medicine differentiation, the result of clinical tests. When the patient discharge, we will write down the treatment measures, therapeutic effect, length of stay and the costs.

Official Title
-----------------
The Clinical Study of Acute Pancreatitis With Gastrointestinal Dysfunction Treated by TongFuSan for External Application on ShenQue Acupoint

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Drug: TongFuSan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of acute pancreatitis，both mild type and severe type Exclusion Criteria: pregnant or suckling cancer in late time patient near death

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: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TongFuSan<br>TongFuSan 1g per time, change every day, the duration is seven days | Drug: TongFuSan<br>* TongFuSan 1g<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of first defecation |  | ten days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of bowel sounds getting back to normal |  | ten days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute pancreatitis, gastrointestinal dysfunction, TongFuSan, ShenQue acupoint
oncoFISH Cervical Test for Detection of 3q26 Region Gain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of the oncoFISH cervical test system in the management of women who have received an LSIL Pap report to determine whether the test can predict which women will progress to more serious cervical disease and which women do not have to be monitored as closely.

Official Title
-----------------
The oncoFISH Cervical Test for Detection of 3q26 Region Gain

Conditions
-----------------
Cervical Cancer, LSIL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 21 years of age or greater with recent LSIL who are scheduled for colposcipal assessment. Women with previous or current STD or HIV may be included Women with previous LSIL history may be included. Exclusion Criteria: pregnant women, women with vaginal intraepithelial lesions, women on a chemotherapeutic agent, women with previous or current cancer except for non-cervical squamous cell carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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 |
| --- | --- |
| LSIL<br>Women 21 years of age or older with an LSIL diagnosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |