linjc16/ctgov huggingface dataset:
Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Study Overview
=================
Brief Summary
-----------------
To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.

Official Title
-----------------
Rotational Stability of Different Intraocular Lenses in The Capsular Bag

Conditions
-----------------
Intraocular Lens Complication, Phacoemulsification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark. The operation was smooth and there were no surgical complications. Exclusion Criteria: Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.); History of ocular trauma or surgery before this cataract surgery; intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation; Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;

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 |
| --- | --- | --- |
| Alignment of intraocular lens | The alignment of intraocular lens was evaluated by anterior segment photography | 1 day postoperatively | 
| Alignment of intraocular lens | The alignment of intraocular lens was evaluated by anterior segment photography | 1 week postoperatively | 
| Alignment of intraocular lens | The alignment of intraocular lens was evaluated by anterior segment photography | 1 month, postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure | Intraocular Pressure measured by non-contact tonometers | 1 day, 1 week, 1 month, postoperatively | 
| Corrected Visual Acuity (UCVA) at Distance | UCVA was determined by subjective refraction | 1 day, 1 week, 1 month, postoperatively | 
| Uncorrected Visual Acuity (UCVA) at Distance |  | 1 day, 1 week, 1 month, postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotation, Postoperative Care
ECG Vector Determination

Study Overview
=================
Brief Summary
-----------------
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.

Detailed Description
-----------------
This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data and determine the process for proper generator and lead placement. The study will be conducted in two phases: Phase I includes ECG data collection from human subjects; Phase II, the Implant Instructions for Use will be evaluated by Cyberonics' Clinical Engineers based on the activities of five to eight experienced VNS surgeons.

Official Title
-----------------
ECG Vector Determination for Model 106 Generator Implant Site Selection

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II. Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study. Exclusion Criteria: History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator. Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI. History of physical adverse reaction to adhesive electrodes.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| healthy patients, may have epilepsy<br>Subjects at least 12 years old and in general good health for Phase I, and at least 18 years old and in general good health for Phase II. It is desired, but not required, for subjects to have epilepsy and taking at least 1 antiepileptic medication. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate ECG amplitude with prospective VNS implant sites. | This study is designed to collect ECG data to determine the process for proper generator and lead placement. | up to 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify potential VNS implant sites associated with low ECG amplitudes. |  | up to 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, ECG, device placement
Sitosterolemia Extension Study (0653-004)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This is an extension study for patients having unusually high absorption of non-cholesterol sterols, resulting in heart-related diseases. This study will evaluate the long term safety and the ability to lower cholesterol levels with an investigational drug.

Detailed Description
-----------------
The duration of treatment is 52 weeks.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia

Conditions
-----------------
Lipid Metabolism, Inborn Errors, Heart Disease

Intervention / Treatment
-----------------
* Drug: MK0653, ezetimibe
* Drug: Comparator: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with elevated sitosterol levels while taking current medication Exclusion Criteria: Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Ages Eligible for Study
-----------------
Minimum Age: 10 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

| Intervention/Treatment |
| --- |
|Drug: MK0653, ezetimibe|nan|
|Drug: Comparator: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma sitosterol levels after 52 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma LDL-C and plasma campesterol. Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Homozygous Sitosterolemia
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Study Overview
=================
Brief Summary
-----------------
The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.

Official Title
-----------------
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

Conditions
-----------------
Blood Coagulation Disorders, Hemophilia A

Intervention / Treatment
-----------------
* Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* Patients under daily life treatment receiving Kogenate according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of FVIII |  | After 12 months and after 24 months | 
| Number of bleedings |  | After 12 months and after 24 months | 
| Kind of bleedings |  | After 12 months and after 24 months | 
| Continuation of therapy |  | After 12 months and after 24 months | 
| Overall assessment by the physician |  | After 12 months and after 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | After 12 months and after 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Octocog alfa, Hemophilia A
Usage and Plan of Care Changes Due to Drug Screenings

Study Overview
=================
Brief Summary
-----------------
The purpose of this minimal risk, observational survey is to document the accuracy, benefits, and how qualitative and quantitative results affect patients' plan of care.

Detailed Description
-----------------
Pain is the most common reason patients consult primary care providers. According to recent surveys, One in six Americans live with chronic or recurrent pain and pay an estimated $120 billion a year in medical costs in the United States. Oral opioids are the common treatment options for various chronic pains including joint pain, musculoskeletal pain, neuropathic pain and migraines. This narcotic-based management of pain is often associated with undesirable side effects with addictive and potential abuse. To ensure proper usage of prescribed medications, physicians use drug screens to monitor therapeutic levels and test for presence of illegal drugs or medications that may cause a drug-drug interaction. Upon receiving quantitative or qualitative results from these drug screens, the physician may change the treatment plan for patients to improve efficacy of prescribed medications.

Official Title
-----------------
Clinical Researcher Experience Assessment Documenting Usage and Plan of Care Changes Due to Drug Screenings ©

Conditions
-----------------
Pain Management

Intervention / Treatment
-----------------
* Other: Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a Medical Practioner Medical Doctor (MD) Doctor of Osteopathic (DO) Physician Assistant (PA) Advanced Practice Registered Nurse (APRN) Nurse Practioner (NP) Must have a current standard operating procedure that includes obtaining/reviewing medical history. Exclusion Criteria: Government-funded insurance data cannot be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plan of Care Changes due to Drug Screenings | Provider based observational survey | 3 years |
Systemic Reactions to Allergen Immunotherapy Amd Skin Testing

Study Overview
=================
Brief Summary
-----------------
Allergy skin tests and allergen immunotherapy are common procedures for both the diagnosis and treatment of atopic diseases. Allergen immunotherapy has proved to be effective in reducing the symptoms of allergic rhinitis and asthma1-2. Despite its clinical benefit, there is risk of systemic reactions associated with these procedures. The systemic reaction rate to skin testing for aeroallergens is significant lower than the rate of reactions to immunotherapy, but it is not negligible. Lin et al reported only 2 patients who had systemic allergic reactions to skin testing for respiratory allergies in 10,400 patients tested.3 They determined the overall risk of inducing anaphylactic reactions by skin testing to be less than 0.02% and other studies have produced similar results.4-5 The rate of systemic reactions to skin testing is likely underscored. Thompson et. al reported a systemic reaction rate of 6% of patients receiving skin testing.6 It is important to recognize the risk of systemic reactions seeing skin testing is commonly done. It is also imperative to recognize the treatments for these reactions to prevent progression. Hypothesis The systemic reaction rate to allergen immunotherapy and skin testing to aeroallergens is higher than previously reported. Biphasic anaphylactic reactions rarely occur with allergen immunotherapy and skin testing.

Official Title
-----------------
Systemic Reactions to Allergen Immunotherapy Amd Skin Testing

Conditions
-----------------
SYSTEMIC REACTION

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice. Exclusion Criteria: NON Male and female subjects who are receiving skin testing or allergen immunotherapy from one allergy practice.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHART REVIEW ONLY<br>CHART REVIEW OF PATIENTS WITH SYSTEMIC REACTIONS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is a prospective observational study of patients who are having either skin testing or allergen immunotherapy for the diagnosis or treatment of allergic rhinitis, conjunctivitis, and/or asthma. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ALLERGIC REACTION
Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Patients with cancers that are sensitive to radiotherapy treatment and/or patients who have experienced severe acute/ late side effects to radiotherapy will be recruited to the study. Blood and/or matched tumour-normal tissue pairs will be collected. Blood and/or tissue samples will be processed and studied for genetic and biochemical markers that have potential to be used for predicting sensitivity to radiation.

Official Title
-----------------
Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

Conditions
-----------------
Nasopharyngeal Cancer, Prostate Cancer, Other Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe side effects from radiotherapy Patients with a type of cancer that is associated with sensitivity to radiotherapy Exclusion Criteria: Age of patient must be between 21 (inclusive) and 99 (exclusive)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| To identify genes or molecular pathways that are associated with radiation sensitivity in blood and tissue samples | Whole exome sequencing, single nucleotide polymorphism (SNP) assays | Blood is taken at informed consent; tissue is from archived sample | 
| Change in immune profile of blood and tissue after radiation | Mass cytometry using CyTOF technology will be used to detect the immune cell population | Blood is taken at informed consent; tissue is from archived sample | 
| To identify proteins that are associated with radiation sensitivity in tissue samples | Immunohistochemistry will be used to detect protein expression | Tissue is from archived sample | 
| To identify RNA expression pathways that are associated with radiation sensitivity in blood and tissue samples | RNA sequencing | Blood is taken at informed consent; tissue is from archived sample | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Biomarkers, Genomics, Immunomics, Precision medicine
VIC Regimen Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
In this study, we compared first-line VIC regimen with chemotherapy plus bevacizumab in Chinese patients with initially unresectable BRAF V600E-mutated mCRC. The principal goal was to evaluate the safety of VIC regimen, and to investigate the tumor response, the radical resectability, and the patient survival.

Official Title
-----------------
VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Advanced Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: VIC
* Drug: Bevacizumab Plus Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 and ≤80 years old Histologically confirmed colorectal adenocarcinoma Histologically confirmed BRAFV600E mutated and RAS wild-type Initially unresectable metastatic or local CRC ECOG performance status of 0-1 and life expectancy ≥3 months adequate hepatic, renal, and hematologic function Exclusion Criteria: Previously taken any targeted therapy, chemotherapy, intervention therapy, or radiotherapy for CRC within 6 months Other cancers (with the exception of cervical cancer in situ and squamous cell carcinoma of the skin) within the previous 5 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIC<br>VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) | Drug: VIC<br>* VIC Regimen (Vemurafenib/Irinotecan/Cetuximab)<br>|
| Active Comparator: BEV<br>Bevacizumab Plus Chemotherapy | Drug: Bevacizumab Plus Chemotherapy<br>* Bevacizumab Plus Doublet or Triplet Chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival | time from first study treatment to the first documented progression disease or death, whichever occurred first | 3 years | 
| overall survival | time from first study treatment to death from any cause. | 3 years | 
| objective response rate | the proportion of patients with complete response or partial response. | 6 months |
Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis Due to COVID-19

Study Overview
=================
Brief Summary
-----------------
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing. Symphony IL-6 comprises two components, the Symphony Fluorescence Immunoanalyzer and the Symphony IL-6 Cartridge. Whole blood is added to the cartridge and then up to six cartridges can be inserted into the immunoanalyzer. After 20 minutes a readout and printout are given with a quantitative IL-6 concentration. The used cartridges are fully enclosed and can be easily disposed of in general hospital bio-waste. Given the nature of this device and its portability, there is potential for future deployment as a point-of-care (POC) device. This study is to establish an interleukin-6 (IL-6) cutoff value using the Symphony IL-6 test for patients at high risk of severe sepsis caused by a COVID-19 infection.

Official Title
-----------------
Symphony IL-6 Cutoff Establishment Study for Patients at Risk of Severe Sepsis

Conditions
-----------------
Severe Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Whole-blood specimen collected in K2 EDTA anticoagulant tubes Subject is considered to have severe or critical illness per below: Severe Illness SpO2 < 94% on room air at sea level; Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg; Respiratory frequency > 30 breaths/min; Or lung infiltrates >50% Critical Illness a) Respiratory failure; b) Septic shock; c) And/or multiple organ dysfunction d) At least one criterion of severe illness Subject confirmed to be COVID-19 positive by an EUA RT-PCR test Subject is 18+ years of age Minimum volume of 100µL for Symphony IL-6 testing Specimen is available for testing within 12 hours from collection Exclusion Criteria: Subject is receiving an anti-IL-6 treatment Subject is receiving corticosteroids Hemolyzed specimens

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Measurement of IL-6 Concentration in Patients at High Risk of Severe Sepsis | Determine the interleukin-6 concentration in whole blood samples from patients with confirmed COVID-19 infection and are at high risk of septic shock. | Specimen is tested within 12 hours from collection |