linjc16/ctgov huggingface dataset:
Retinal Pigment Epithelium Safety Study For Patients In B4711001

Study Overview
=================
Brief Summary
-----------------
This is a safety follow-up study. Patients enrolled in B4711001 will be followed for a further 4 years with regular visits to assess safety.

Official Title
-----------------
Long Term, Open-Label, Safety Follow Up Study Following Transplantation Of Pf-05206388 (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)) In Subjects With Acute Wet Age Related Macular Degeneration And Recent Rapid Vision Decline

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. Previous participation in Protocol B4711001 and received treatment with PF-05206388. Subjects who are willing and able to comply with scheduled visits, and study procedures. Exclusion Criteria: there are no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| observation<br>subjects treated in B4711001 with PF-05206388 will be assessed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of serious adverse events and ocular adverse events | incidence of serious adverse events and ocular adverse events will be monitored | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA) | Change from baseline (pre-implantation) in ETDRS (Early Treatment of Diabetic Retinopathy Study) best corrected visual acuity (BCVA). The Proportion of subjects with an improvement of 15 letters or more at all timepoints will be assessed | 4 years | 
| Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints. | Mean ETDRS BCVA and change from baseline (pre-implantation) at all timepoints will be assessed | 4 years |
Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of triamcinolone acetonide in silicone-filled eyes on the outcome of surgery for PVR.

Conditions
-----------------
Proliferative Vitreoretinopathy

Intervention / Treatment
-----------------
* Drug: Triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases of rhegmatogenous retinal detachment complicated by PVR grade C undergoing vitrectomy and silicone oil tamponade. Exclusion Criteria: History of trauma Presence of diabetic retinopathy History of vein occlusion Giant retinal tear

Ages Eligible for Study
-----------------
Minimum Age: 0 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

| Intervention/Treatment |
| --- |
|Drug: Triamcinolone acetonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-operation retinal reattachment rate six |  |  | 
| months after surgery. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Retinal reproliferation |  |  | 
| Intraocular pressure |  |  | 
| Early silicone oil emulsification |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PVR, Retinal detachment, Silicone oil, Triamcinolone
Use of Graft Tensioner Device in ACL (Knee) Repair

Study Overview
=================
Brief Summary
-----------------
Compares tension of an ACL graft when using a commercial device vs. the tension of the graft applied by a physician during surgery.

Official Title
-----------------
Randomized Clinical Trial to Assess the Clinical Effectiveness of a Measured Objective Tensioning in Hamstring ACL Reconstruction

Conditions
-----------------
Torn Anterior Cruciate Ligament (Knee)

Intervention / Treatment
-----------------
* Procedure: ACL surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Torn ACL amenable to surgery Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Intervention/Treatment |
| --- |
|Procedure: ACL surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints Measured at 6, 12, 18 months post op compared to pre-op |  |  |
Association Between Depression and Iron Metabolism in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study assesses the association of depression symptoms and iron metabolism in patients undergoing hemodialysis.

Detailed Description
-----------------
The Beck Depression Inventory (BDI), second version, was used to quantify the levels of depression. Mean age, duration of HD, hemoglobin levels, serum ferritin levels, serum iron levels, TSAT, TIBC, serum albumin levels, CRP and energy consumption (kcal/week) were included in the model as multivariate variables. Backward stepwise logistic regression (ROC) analysis was performed.

Official Title
-----------------
Association Between Depression and Iron Metabolism in Hemodialysis Patients

Conditions
-----------------
Hemodialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable undergoing hemodialysis Exclusion Criteria: Patients those who refused to join present study, and those who could not complete the questionnaires by themselves, and the patients with chronic hepatitis B or C were excluded.
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 |
| --- | --- | --- |
| Measurement of depression status | Using The Beck Depression Inventory | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The values of serum ferritin | Measuring serum ferritin levels as iron metabolism | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression
Treatment of Fibromyalgia With Recovery Factors

Study Overview
=================
Brief Summary
-----------------
Treatment of Fibromyalgia and CFS with Recovery Factors

Detailed Description
-----------------
Use of a unique oral porcine peptide nutritional supplement in those meeting ACR 2010(amended) diagnostic criteria for Fibromyalgia or CDC Criteria for CFS

Official Title
-----------------
Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support

Conditions
-----------------
Fibromyalgia, Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Recovery Factors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS Exclusion Criteria: Under 18 Pregnant Other severe complicating conditions -

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
Intervention Model: Single Group Assignment
Interventional Model Description: Open pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Assessing clinical outcomes<br>Nutritional support with Recovery Factors | Dietary Supplement: Recovery Factors<br>* A unique porcine serum based polypeptide nutritional support<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite VAS | Composite of VAS for Fatigue, sleep, cognition, pain and overall well being | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FIQ-R | Fibromyalgia Impact Questionnaire | 1 month |
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed with Behcet's disease will be randomized to administeration of hydroxychloroquine. Assessment will be done for the patients at baseline and every one month in the first three months and then quarterly for one year.

Official Title
-----------------
The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention

Conditions
-----------------
Behcet's Syndrome, Vascular Type

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed with Behcet's disease on any DMARDs Exclusion Criteria: Patients with critical conditions Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydroxychloroquine arm<br> | Drug: Hydroxychloroquine<br>* the drug will be taken by one group of the patients daily at a dose of 400mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of the recurrence of thrombotic events | number of relapses is expected to fall with the longterm use of the drug | 6 months- one year |
Superiority of Epidural Placement Technique Using EpiFaith Syringe

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Detailed Description
-----------------
We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

Official Title
-----------------
Superiority of Epidural Placement Technique Using EpiFaith® Syringe Versus Conventional Glass Syringe in Laboring Paturients

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: Syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females 18 years of age and older at screening Request labor epidural analgesia Able to give informed consent to participate in the study American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status BMI ≤ 40 kg/m2 Exclusion Criteria: BMI > 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection) Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks Any allergy to bupivacaine or fentanyl

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EpiFaith® group<br>Study subject will have the epidural placement with an EpiFaith® syringe. | Device: Syringe<br>* A syringe will be used to detect the loss of resistance and needle's entry of epidural space.<br>|
| Active Comparator: Conventional group<br>Study subject will have the epidural placement with a conventional glass syringe. | Device: Syringe<br>* A syringe will be used to detect the loss of resistance and needle's entry of epidural space.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of epidural localization | Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture | 30 minutes |
Flipped Autograft for Treating Surgical Wound Dehiscence

Study Overview
=================
Brief Summary
-----------------
This case report describes a novel technique for management of peri-implant wound dehiscence that involves using auto graft from the same surgical site to seal the dehiscence defect.

Official Title
-----------------
Flipped Autograft: a Novel Approach for Management of Wound Dehiscence in Implant Dentistry

Conditions
-----------------
Wound Dehiscence

Intervention / Treatment
-----------------
* Procedure: flipped autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients in a healthy systemic condition. Both genders Patients should have single missing tooth. Seibert Class I ridge defect. Patients should approve to deliver a signature to a written consent after study nature explanation. Exclusion Criteria: 1- Patients with any smoking habits. 2- Pregnant females, decisional impaired individuals, Prisoners and handicapped patients. 3- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures. 4- Patients with infections either periodontally or periapically.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: flipped autograft<br> | Procedure: flipped autograft<br>* Thick lingual flap was de-epithelized and partially dissected to increase its length then flipped and sutured to the buccal flap to obtain primary closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete primary intention healing of the wound dehiscence | complete uneventful healing will be assessed clinically by measuring soft tissue width and thickness using periodontal probe under local anesthesia | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| esthetic outcome and patient satisfaction. | esthetic outcome will be measured using pink esthetic score. Pink esthetic score (PES) will be recorded for five variables: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site. A score of 2, 1, or 0 will be assigned to all five parameters. also patient satisfaction will be recorded using: • (VAS) Visual analogue scale to measure postoperative pain. Pain score reported by the patient. directly through Visual Analogue Scale score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain) which will be recorded after 2 weeks (Yildirim et al., 2017) | 3 months |
Evaluation of Viral Shedding Patterns and Clinical Outcomes of Influenza Patients

Study Overview
=================
Brief Summary
-----------------
The objective of the study is virological assessment (e.g., proportion of prolonged viral shedding, median days to viral clearance, and viral load) in laboratory-confirmed adult influenza patients admitted to the general ward and/or to the ICU and to assess the correlation with the clinical manifestations and prognosis.

Official Title
-----------------
Prospective Study to Evaluate Viral Shedding Patterns and Clinical Outcomes of Hospitalized Adult Influenza Patients

Conditions
-----------------
Influenza

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Hospitalized or admitted to ICU for influenza Age ≥18 years Laboratory confirmation of influenza A or B Exclusion Criteria: Informed consent not given

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 |
| --- | --- |
| Inpatient cohort<br>Patients admitted to general wards | |
| ICU cohort<br>Patients admitted to ICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load/Viral shedding | Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) | Day 7 | 
| Viral load/Viral shedding | Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) | Day 9 | 
| Viral load/Viral shedding | Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) | Day 11 | 
| Viral load/Viral shedding | Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) | Day 13 | 
| Viral load/Viral shedding | Outcome is the decay rate in viral load during hospital stay measured by quantitative polymerase chain reaction (QPCR) | Day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Virus, Viral shedding, Epidemiology
Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level

Study Overview
=================
Brief Summary
-----------------
Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the universal prevention level, developed by Swedish researchers for the school years 4 -9. By defining and teaching school rules to all teachers and students, and by consistently acknowledging students when meeting behavioural expectations, the program aims to reduce problem behaviours in school areas and to improve the classroom learning climate. Against this background, the purpose of this study is to examine whether PS is more effective than schools' ordinary practices in meeting these goals.

Conditions
-----------------
Problem Behaviors Among Students, Classroom Learning Environment

Intervention / Treatment
-----------------
* Behavioral: PS - Prevention in School


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schools situated in Stockholm county and in bordering counties within travelling distance from Stockholm. Comprising the grades 4-9 (10-15 years). A minimum of 2 classes/50 students in each of the grades 5-7. A majority (min.80%)of the staff is positive towards program participation. School management willing to take active part in change/developmental work. A willingness to submit to study conditions (randomization etc) Exclusion Criteria: Participation in other ongoing research projects.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS - Prevention in School<br>Teachers learn to use the core program components (defining and teaching school rules and the handling of rule breakings, principles of positive behavior support)with help from external consultants during approximately 1.5 years. | Behavioral: PS - Prevention in School<br> <br> |
| No Intervention: Business as usual<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Student problem behaviors | Teacher-reported problem behaviors in school areas during last week Teacher-reported problem behaviors in classrooms during last week Student-reported problem behaviors in school areas during the school-year Student-reported problem behaviors in classrooms during the school-year | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classroom learning climate | Teacher self-reports; Teacher Classroom Climate Scale Student self-reports; Student Classroom Climate Scale | 24 months |