linjc16/ctgov huggingface dataset:
Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

Official Title
-----------------
Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia

Conditions
-----------------
Keratoconus and Ectasia

Intervention / Treatment
-----------------
* Drug: Riboflavin
* Device: VEGA UV-A Illumination System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12 years of age or older Diagnosis of Keratoconus or Ectasia Central or Inferior steepening on the Pentacam map Topography consistent with Keratoconus or Ectasia BSCVA 20/20 or worse Removal of contact lenses for required period of time Signed written informed consent Willingness and ability to comply with schedule for follow up visits Exclusion Criteria For Keratoconus, a history of previous corneal surgery Corneal pachymentry equal to or greater and 400 Previous ocular condition in the eyes to be treated that may predispose the eye for future complications A history of chemical injury or delayed healing Pregnancy A known sensitivity to the study medications Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests Presence or history of any other condition or finding that makes the patient unsuitable as a candidate

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CXL Treatment<br>All eyes to be treated with riboflavin and UV light | Drug: Riboflavin<br>* Riboflavin is a solution that will be delivered to the treatment area<br>Device: VEGA UV-A Illumination System<br>* This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Corneal Curvature |  | 24 MO |
EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

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 Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

Conditions
-----------------
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 |
| --- | --- | --- |
| Efficacy and Safety of Kogenate FS |  | After 12 months and after 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Octocog alfa, Hemophilia A
Intraosseous Access During Pediatric Resuscitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.

Official Title
-----------------
A Comparison of Four Intraosseous Access Devices With Standard Venous Catheterization During Child Cardiopulmonary Resuscitation Simulation: a Randomized Crossover Trial.

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Peripheral venous catheterization
* Device: Jamshidi
* Device: BIG
* Device: Cook
* Device: EZIO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: give voluntary consent to participate in the study minimum 1 year of work experience in emergency medicine experienced emergency medical personnel - EMS-paramedics Exclusion Criteria: not meet the above criteria wrist or low back diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral venous catheterization<br>Peripheral venous catheterization during pediatric resuscitation | Device: Peripheral venous catheterization<br>* Cannulation using standard method<br>|
| Experimental: intraosseous access<br>Intraosseus access using intraosseous access devices during resuscitation | Device: Jamshidi<br>* intraosseous access using the Jamshidi device<br>Device: BIG<br>* intraosseous access using the BIG device<br>* Other names: Bone Injection Gun;Device: Cook<br>* intraosseous access using the Cook device<br>Device: EZIO<br>* intraosseous access using the EZIO device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate on first attempt |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Ease of use as reported by participants | 1 day | 
| Time to successfully perform | Time to successfully perform the intraosseous access | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheterization, Peripheral
Local and Systemic Changes in Osteonecrosis of the Jawbone

Study Overview
=================
Brief Summary
-----------------
Osteonecrosis of the Jawbone (ONJ) is a serious complication of antiresorptive therapies (ARTs), for example with bisphosphonates or Denosumab. Especially long term treatment with intravenous antiresorptive agents causing lesions and, less frequent, also oral administration. This study aims at elucidating local and systemic changes in patients with ONJ.

Official Title
-----------------
Pilot Study: Local and Systemic Changes in Osteonecrosis of the Jawbone

Conditions
-----------------
Osteonecrosis of the Jaw

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older with/without ART with/without MRONJ Exclusion Criteria: smoker (>10 cigarettes/day) pregnancy

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 |
| --- | --- |
| Healthy Controls<br> | |
| Patients with ART without MRONJ<br> | |
| Patients with oral ART with MRONJ<br> | |
| Patients with intravenous ART with MRONJ<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target gene expression | differences in gene expression recorded by qPCR will be assessed | through study completion, an average of 1 year |
Effectiveness of Lumbar Traction in Lumbar Disk Herniation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the clinical outcome of medical treatment associated with lumbar traction and medical treatment alone in the treatment of lumbar disk herniation.

Detailed Description
-----------------
This is a prospective and randomized study. Medical treatment = anti-inflammatory therapy and epidural Medical treatment associated with lumbar traction medical treatment = + 5 lumbar traction sessions.

Official Title
-----------------
Clinical Results After Medical Therapy Alone or Medical Therapy Associated With Lumbar Traction in the Treatment of Nerve Root Pain of Lumbar Disc Herniation With Disco-radicular Conflict

Conditions
-----------------
Lumbar Disk Herniation

Intervention / Treatment
-----------------
* Other: cortivazol treatment
* Other: lumbar traction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion : patient with lumbar disc herniation with radiculopathy, over 18 years and consenting Exclusion : sciatic complicated (motor deficit or cauda equina syndrome), against indication for medical treatment and / or lumbar traction previous lumbar surgery sciatica without disc herniation

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cortivazol<br>anti-inflammatory therapy and epidural | Other: cortivazol treatment<br> <br> Other: lumbar traction<br> <br> |
| Experimental: Traction arm<br>Medical treatment associated with 5 lumbar traction sessions | Other: lumbar traction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease radicular pain (25%) |  | to 4 weeks |
PPI Versus Histamine Antagnists as Adjuvant to Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma.

Detailed Description
-----------------
The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump Inhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma to compare the difference in efficacy.

Official Title
-----------------
Comparative Clinical and Biochemical Study Evaluating the Effect of Proton Pump I Nhibitors Versus Histamine 2 Receptor Antagonists as an Adjuvant With Chemotherapy in Patients With Non-hodgkin Lymphoma.

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: CHOP
* Drug: CHOP Plus Lanzoprazole
* Drug: CHOP Plus Famotidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DLBCL Lymphoma subtype --No comorbid disease Exclusion Criteria: Pregnancy Peptic ulcer Severe cardiac disease Osteoporosis

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHOP<br>CHOP only | Drug: CHOP<br>* CHOP only<br>* Other names: CHOP protocol;|
| Active Comparator: CHOP Plus Lanzoprazole<br>CHOP Plus Lanzoprazole 60 mg | Drug: CHOP Plus Lanzoprazole<br>* CHOP plus Lanzoprazole 60 mg<br>* Other names: CHOP Plus Lanzoprazole 60;|
| Active Comparator: CHOP Plus Famotidine<br>CHOP Plus Famotidine 40 mg | Drug: CHOP Plus Famotidine<br>* CHOP Plus Famotidine 40 mg<br>* Other names: CHOP Plus Famotidine 40;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients eith radiological and clinical improvement | Number of patients eith radiological and clinical improvement after cycles of chemotherapy | 6 months |
A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
In asymptomatic Stage 4 colorectal cancer, the treatment varies between many hospitals and countries. Some studies found that primary tumor resection had better survival rates and a lower risk of mortality. But many studies found significant benefits in survival in sub groups of the population such as age less than 70 years, WHO performance status <2, no extra-hepatic metastasis, liver tumor burden <50%. However some studies showed no survival benefits in primary tumor resection. So this study will focus on survival, adverse events, complications in primary tumor resection and no primary tumor resection in asymptomatic Stage 4 colorectal cancer.

Detailed Description
-----------------
The retrospective study of patients in asymptomatic Stage 4 colorectal cancer received treatment at Ramathibodi Hospital and excluded symptomatic primary tumors such as obstruction, perforation that required surgery, carcinomatosis peritoneii, and patients with secondary cancer diagnosis in the past 5 years.

Official Title
-----------------
A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer : Primary Tumor Resection vs. No Primary Tumor Resection

Conditions
-----------------
Stage IV Colon Cancer

Intervention / Treatment
-----------------
* Procedure: primary tumor resection group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic stage IV colorectal cancer pathological prove adenocarcinoma age >18 years no primary tumor related symptom ECOG performance status <2 Exclusion Criteria: symptomatic primary tumor such as obstruction , perforation that required surgery carcinomatosis peritoneii patients with secondary cancer diagnosis in 5 years

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

| Intervention/Treatment |
| --- |
|Procedure: primary tumor resection group|resection of cancer at colon|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | The definition of complication defined as symptom that occurred during treatment period such as obstruction , perforation , bleeding , trenesmus. | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The survival time | The survival time defined as time from diagnosis to death or last follow up period | 5 year |
A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess Cardiac Electrical Function

Study Overview
=================
Brief Summary
-----------------
The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves. The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective cardiac catheterization or electrophysiology procedures; 2. patients coming for outpatient cardiology appointments; 3. Inpatients admitted with a cardiac diagnosis. The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain the ECG.

Official Title
-----------------
A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function

Conditions
-----------------
Cardiac Electrical Function

Intervention / Treatment
-----------------
* Device: 12 Lead Glove


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preop assessment for elective cardiac catheterization or EP procedure. Outpatient cardiology appointments. Inpatients admitted with a cardiac diagnosis Exclusion Criteria: Age less than 18. Skin breakdown.

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 |
| --- | --- |
| 1<br>Cardiac Inpatient | |
| 2<br>Cardiac Outpatient | |
| 3<br>Cardiac Clinic Patient | Device: 12 Lead Glove<br>* Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of Hand ECG to standard ECG with physician over-read |  | 1 year |
Development of a Fetal Sex Assay From Maternal Whole Blood

Study Overview
=================
Brief Summary
-----------------
Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.

Detailed Description
-----------------
This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.

Official Title
-----------------
Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation

Conditions
-----------------
Fetal Sex Determination

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18-64 years of age Subject is female Subject is pregnant and between 6 and 16 weeks of gestation Subject provides a signed and dated informed consent If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results If subject undergoes an invasive procedure, she agrees to provide the fetal sex results Exclusion Criteria: None

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant females<br>Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age. | |

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
-----------------
pregnant, fetal sex determination, gender determination, noninvasive test, fetal DNA
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis

Study Overview
=================
Brief Summary
-----------------
In this study will be consecutive enrolled children with asthma (classified according to GINA guidelines) and rhinitis (classified by ARIA guidelines); the investigators will research clinical personal and parental history regarding allergic diseases, exposition to passive smoking and interpretate hematochemical parameters markers of atopy. Skin Prick Tests will be performed. In this study the investigators will evaluate lung function parameters (spirometry with bronchial reversibility test and exercise induced bronchoconstriction, oscillometry, respiratory plethysmography, etc.), airway inflammatory indices such as exhaled nitric oxide at different flows, exhaled and nasal temperature, nasal cytology. The aim of the study will be to evaluate possible correlation between these different parameters and clinical status of the patients.

Detailed Description
-----------------
Each patients will be evaluated by spirometry and then he will undergo exercise challenge in order to evaluate exercise-induced bronchoconstriction as a marker of asthma control. The test of the challenge will be correlate with childhood Asthma control test score,levels of control (GINA classification)and the different markers of airway inflammation and atopy.

Official Title
-----------------
Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis

Conditions
-----------------
Asthma, Rhinitis

Intervention / Treatment
-----------------
* Other: regular treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with asthma and rhinitis Exclusion Criteria: age <5 years chronic respiratory diseases

Ages Eligible for Study
-----------------
Minimum Age: 5 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 |
| --- | --- |
| asthma and rhinitis control<br> | Other: regular treatment<br>* regular treatment<br>* Other names: asthma treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis |  | Evaluation of Different Disease Control Indices in Children With Asthma and Rhinitis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, rhinitis, EIB, Exhaled Nitric oxide, lung function, vitamin d