linjc16/ctgov huggingface dataset:
Assessment of Prototype Hand-Held Fundus Camera

Study Overview
=================
Brief Summary
-----------------
Assessment of handheld fundus images in comparison to conventional fundus camera images.

Detailed Description
-----------------
This study is comparing a small handheld camera with a standard fundus camera for image quality

Official Title
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Assessment of Prototype Hand-Held Fundus Camera

Conditions
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Normal Subject Population

Intervention / Treatment
-----------------
* Device: Handheld fundus photography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > 18 The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study. The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve. Exclusion criteria: Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject. Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fundus imaging<br>retinal photograph obtained at visit | Device: Handheld fundus photography<br>* diagnostic imaging with two types of retina camera<br>* Other names: imaging only;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of photographs that score a 3 or higher on the grading scale | Photos will be evaluated by ophthalmologists and scored as follows: Unacceptable: cannot see fundus detail Unacceptable: fundus detail visualized, but inadequate for meaningful analysis Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use Good: fundus detail visualized, meaningful analysis possible, standard photograph superior Excellent: fundus detail visualized as well as standard photograph Superior: fundus detail of higher quality than standard photograph | 2-3 years |
Audit of the Response Time of the Anaesthetic and Surgical Techniques for Crash Caesarean Section

Study Overview
=================
Brief Summary
-----------------
A decision-to-delivery interval of 30 minutes for category-1 Caesarean section deliveries is the standard of practice recommended by clinical guidelines.

Detailed Description
-----------------
Our institution established a protocol for category-1 ('crash') CS to expedite deliveries. This retrospective audit evaluated all women who underwent category-1 CS in KK Women's and Children's Hospital from 2010 to 2013.

Official Title
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Audit of the Response Time of the Anaesthetic and Surgical Techniques for Crash Caesarean Section

Conditions
-----------------
Pregnancy, Anaesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Category One Caesarean Section at KK Women's and Children's Hospital, Singapore between 2010 to 2013. Exclusion Criteria: No specific exclusion criteria, retrospective audit

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| Decision to delivery interval | Decision for Caesarean section to delivery of foetus | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General anaesthesia | Rate of general anaesthesia | 1 hour | 
| Neonatal outcome | APGAR score and cord pH | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caesarean section, Emergency, Anaesthesia
Brachial Plexus Block in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
This study involves a retrospective evaluation of brachial plexus anaesthesia in children and adolescents (patients under the age of 18) undergoing surgical procedures of the upper extremity following trauma. The investigators plan to recruit patients from our hospital patient database meeting our inclusion criteria. Observational period was defined between 1st of January 2002 and 31st of October 2018. Necessity to convert to general anaesthesia was defined as primary endpoint.

Official Title
-----------------
Brachial Plexus Block in Children and Adolescents Requiring Surgery Following Trauma

Conditions
-----------------
Upper Extremity Fracture

Intervention / Treatment
-----------------
* Procedure: Brachial Plexus Anaesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brachial plexus anaesthesia for surgical intervention of upper extremity injuries Exclusion Criteria: age above 18

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Study Group<br>All patients under the age of 18 who were treated for upper extremity injuries between 2002 and 2018 and receiving brachial plexus anaesthesia. | Procedure: Brachial Plexus Anaesthesia<br>* Regional anaesthesia for treatment of upper extremity injuries.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to general anaesthesia | The necessity to convert to general anaesthesia will be obtained from surgery and anaesthesiology protocols and serves as primary outcome to evaluate efficacy of the investigated method of anaesthesia. All patients who received plexus brachialis anaesthesia but had to be converted to general anaesthesia during or prior the surgical intervention will assigned to this outcome measurement. Number of patients who required conversion will be given as percentage of total patient collective. Possible variables: e.g. 0=no conversion, 1=conversion. | intraoperatively |
Ovarian Tissue Transplantation

Study Overview
=================
Brief Summary
-----------------
Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.

Official Title
-----------------
Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue

Conditions
-----------------
Infertile Females or Females With Ovarian Insufficiency

Intervention / Treatment
-----------------
* Procedure: Transplantation of previously cryopreserved ovarian tissu


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient between the ages of 18 and 45 years Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation Ovarian insufficiency defined as an elevated FSH over 10 Inability to conceive after 6 months of unprotected intercourse with male Reasonably good health Candidate for pregnancy Written clearance for the procedure from the patients oncologist Exclusion Criteria: Patients considered to be high risk for surgical complications will be excluded from the research protocol Women who are known to be positive for the BRCA mutation Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent Current pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Thaw and surgical transplantation of previously collected cryopreserved ovarian cortical tissue
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transplantation of previously cryopreserved ovarian tissue<br>Surgical transplantation of previously collected cryopreserved ovarian cortical tissue. | Procedure: Transplantation of previously cryopreserved ovarian tissu<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy |  | 5 years | 
| Return of menstrual function |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer recurrence |  | 5 years | 
| Surgical Complications of ovarian tissue transplantation | Including infection, hospital readmission, re-operation | 5 years | 
| Acceptability |  | 5 years |
Compliant Analysis of Patient Samples and Data

Study Overview
=================
Brief Summary
-----------------
Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and/or data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.

Detailed Description
-----------------
Arm 1 - Remnant commercial samples and data that has been de-identified of personal health information in compliance with HIPAA may be used for R&D studies or population-based analysis by LabCorp or affiliates. Arm 2 - Collection of samples and/or data from commercial test patients requiring follow-up or from subjects of scientific interest after informed consent is obtained.

Official Title
-----------------
Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies and/or Population-based Analysis

Conditions
-----------------
Cancer, Pregnancy Related, Infectious Disease

Intervention / Treatment
-----------------
* Device: Multiple interventions depending on diagnostic test being run.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arm 1 All samples and data are de-identified and HIPAA compliant Arm 2 Subject is of scientific interest to the Sponsor or treating physician Subject provides written informed consent and has a clinical sample and/or supporting clinical data collected. Exclusion Criteria: Arm 1 Subject is from a US state or a country where local law restricts the use of de-identified data and/or remnants of specimens for research and/or development Arm 2 Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Multiple interventions depending on diagnostic test being run.|Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remnant samples and data for research and development | Remnant samples and data for research and development | Retrospective and Prospective collection. Samples and data may be collected for up 12 months after enrollment. | 
| Sample and data collection from subjects of scientific interest | Collect additional clinical data and samples if needed from subjects tested by LabCorp or an affiliate. | Prospective collection. Samples and data may be collected for up to 12 months after enrollment |
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding.

Official Title
-----------------
Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding

Conditions
-----------------
Gastrointestinal Bleeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent capsule endoscopy in Shanghai Renji Hospital(China) from June 2002 to January 2012 for obscure gastrointestinal bleeding Exclusion Criteria: patients who did not undergo a gastroscopy and colonoscopy performed before capsule endoscopy examination; and patients with follow-up examination for other know clinical diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Rebleeding Rate |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsule endoscopy, obscure gastrointestinal bleeding, rebleeding, risk factors
Short Term Warfarin Therapy for Radiofrequency Catheter Ablation of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
We hypothesized that in patients with low CHADS-VASc score (2 or < 2), there is no difference in thromboembolic or bleeding events between patients with short term warfarin therapy (2 weeks after catheter ablation) and conventional therapy (3 weeks before and 8 weeks after procedure).

Official Title
-----------------
Prospective Randomized Study of Incidence of Thromboembolic and Bleeding Events According to the Period of Warfarin Use Before and After Catheter Ablation of Paroxysmal Atrial Fibrillation in Low Risk Patients

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with paroxysmal atrial fibrillation who underwent radiofrequency catheter ablation Patients with CHADS-VASc score 2 or less than 2 Exclusion Criteria: Patients who do not consent to the study Permanent or persistent atrial fibrillation Patients who have underwent prior catheter ablation for atrial fibrillation CHADS-VASc score more than 2 History of stroke LVEF <40% Significant liver or kidney dysfunction History of major bleeding during warfarin therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short term warfarin group<br>taking warfarin for only 2 weeks after catheter ablation of atrial fibrillation | Drug: warfarin<br> <br> |
| Active Comparator: Conventional therapy arm<br>conventional warfarin therapy of 3 weeks before and 8 weeks after catheter ablation of AF | Drug: warfarin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of thromboembolic and bleeding events during 2 months |  | 2 months after the procedure |
Epstein-Barr Virus as a Possible Cause for Chronic Fatigue Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand what causes a continuing fatigue for a long time with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein Barr Virus is among the group of viruses that have been associated with a continuing fatigue for a long time with a number of symptoms occurring at the same time, but the cause is still unknown.

Detailed Description
-----------------
Epstein-Barr virus (EBV) is the etiological agent for heterophile positive infectious mononucleosis (IM). It is also an oncogenic herpes virus associated with African Burkitt's lymphoma (BL),nasopharyngeal carcinoma (NPC) and AIDS-associated B-cell lymphomas. EBV is also among a group of viruses that have been associated with chronic fatigue syndrome (CFS), although the etiology of CFS still remains unknown.Findings may lead to hypothesize that EBV enzymes, such as the dUTPase, have the capacity to induce immune dysregulation of the T-cell and NK cell responses and that this immune dysregulation produces immunopathology that results in the symptoms that we call CFS.

Official Title
-----------------
Studies on Epstein-Barr Virus as a Possible Etiological Agent for Chronic Fatigue Syndrome

Conditions
-----------------
Chronic Fatigue Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults for controls. Adults with chronic fatigue syndrome. Exclusion Criteria: Individuals with significant medical illness in reference to immunosuppressant drug. Note: We recruit participants in the Mississippi area who could come in our site to provide blood draw.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Fatigue Syndrome, Epstein-Barr Virus
Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a New Packaging Configuration

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to evaluate the product performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a new packaging configuration

Official Title
-----------------
Performance of Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution in a Clear Polyethylene Terephthalate (PET) Bottle.

Conditions
-----------------
Comfort

Intervention / Treatment
-----------------
* Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.
* Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a habitual wearer of planned replacement soft contact lenses VA correctable to 0.3 LogMar or better (driving vision) Clear central cornea Subject uses a lens care system on a regular basis Exclusion Criteria: Systemic disease affecting ocular health Using systemic or topical medications Wear monovision, multifocal or toric contact lenses Any grade 2 or greater slit lamp findings

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ReNu in Currently Marketed Bottle<br>Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle. | Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in the Currently Marketed Resin Bottle.<br>* Daily care for contact lenses.<br>|
| Experimental: ReNu in Clear Resin Bottle<br>Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle. | Device: Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution Packaged in a Clear Resin Bottle.<br>* Daily care for contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Non-inferiority assessment of symptoms/complaints to rate solution comfort. Measurement based on 0-100 scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable rating. | Over-all follow-up visits from baseline to 1 month | 
| Slit Lamp Findings | Graded 0-4 where Grade 0=none; Grade 1=Trace; Grade 2=Mild; Grade 3=Moderate; Grade 4=Severe. | Over-all follow-up visits from baseline to1 month | 
| Lens Deposits | Lens Deposits (All Eligible, Dispensed Eyes) Absent = deposit ratings of none or light; Present = deposit ratings of medium or heavy. | Over-all study visits, baseline to 1-month |