linjc16/ctgov huggingface dataset:
The Italian Transthyretin Amyloidosis Web-Network

Study Overview
=================
Brief Summary
-----------------
The study aims, by generating a large registry of patients with ATTR amyloidosis, including data at diagnosis and during follow up, to describe the natural history of ATTR amyloidosis in a real-world setting and to define and validate prognostic models, response criteria applicable at any point of the disease. The registry will also be used for data sharing and to allow the possibility of a close collaboration amongst the amyloidosis experts of the ARTC and all the physicians around the Country involved in the diagnosis and management of systemic amyloidosis. Thanks to the online registry, the diagnostic facility of the ARTC will be made available to requesting physicians.

Official Title
-----------------
The Italian Transthyretin Amyloidosis Web-Network (ITA-WebNet)

Conditions
-----------------
ATTR Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected diagnosis of systemic and localized amyloidosis; age .18 years; ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted); planned (or ongoing) follow-up at participating center. Exclusion Criteria: 1. Diagnosis of light chain (AL) amyloidosis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Establishing an online tool for data-sharing, available for health care providers | Different data (types type of organ involvement, biomarkers of organ damage, date of onset of symptoms, date of diagnosis, type of treatment (if any)) will be shared between the health-care professionals and the panel of experts. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amyloidosis, systemic amyloidosis
Neoadjuvant Chemotherapy Plus/Minus Surgery in Non-Small-Cell Lung Cancer (NSCLC) Stage IIIA/N2

Study Overview
=================
Brief Summary
-----------------
Hypothesis is that surgery is of benefit in locally advanced NSCLC with N2 disease. Patients are randomised to surgery or not.

Detailed Description
-----------------
Patients are after staging randomised to neoadj. chemotherapy followed by surgery followed by irradiation or to chemotherapy followed by irradiation. Endpoint is survival.

Official Title
-----------------
Scandinavian Neoadjuvant Phase III Study of Induction Chemotherapy Followed by Irradiation Alone or Surgery Plus Irradiation in NSCLC Stage IIIA/N2 (T1N2, T2N2, T3/N2).

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified NSCLC Stage IIIA/N2 age 18-75 Lung function test allowing surgery Mediastinoscopy performed Exclusion Criteria: Prior chemotherapy Prior irradiation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Procedure: Surgery|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N2 disease, Non-small cell lung cancer, Surgery, Neoadjuvant chemotherapy
European Sickle Cell Disease Cohort - Hydroxyurea

Study Overview
=================
Brief Summary
-----------------
In the context of the Risk Management Plan (RMP), as requested from Addmedica by the EMEA, to collect information about long-term safety of Siklos® (hydroxycarbamide) when used in patients with Sickle Cell Disease.

Official Title
-----------------
ESCORT-HU : European Sickle Cell Disease Cohort - Hydroxyurea

Conditions
-----------------
Sickle Cell Disease

Intervention / Treatment
-----------------
* Drug: Siklos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ambulatory patients, aged 2 years and more (children, adolescents or adults) With symptomatic sickle cell syndrome Treated with Siklos® Having been informed of the study by the initiating physician and consenting to participate to the cohort.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Siklos|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Patient-years With Malignancies |  | During the follow-up of participant, up to 10 years | 
| % of Patient-years With Skin Ulcerations | Patients with at least one skin ulceration | During the follow-up of participant, up to 10 years | 
| % of Patient-years With Myelosuppressions | Patients with at least one myelosuppression | During the follow-up of participant, up to 10 years |
The Relationship Between Fasting Time and Delirium

Study Overview
=================
Brief Summary
-----------------
We investigated the relationship between fasting times and delirium in children undergoing MRI under anesthesia. Paediatric Anaesthesia Emergence Delirium (PAED) scale, last oral intake time and type of food (solid-liquid) and fasting time, laryngospasm, desaturation (SpO2 <95%), bradycardia, allergy, nausea and vomiting were recorded.

Official Title
-----------------
The Relationship Between Fasting Time and Emergency Delirium in Pediatric Sedation Undergoing Magnetic Resonance Imaging

Conditions
-----------------
Delirium, Sedation Complication, Magnetic Resonance Imaging, Fasting

Intervention / Treatment
-----------------
* Behavioral: Paediatric Anaesthesia Emergence Delirium scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children between the age group 2-6 years of American Society of Anesthesiologists (ASA) physical status I or II Patients undergoing MRI under sedation Exclusion Criteria: ASA 3-4-5 under 2 years old, over 6 years old cognitive or psychological disorder serious central nervous system diseases, including a brain tumor or uncontrolled seizures type 1 diabetes detection of ≤ 50 mg/dl in fasting blood glucose measurement whose parents did not want to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Paediatric Anaesthesia Emergence Delirium scale|measure emergence delirium in children|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium scale | to measure delirium using the scale | during the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergence delirium, pediatric, preoperative fasting, magnetic resonance imaging
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.

Official Title
-----------------
Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Lotrafilcon A contact lens
* Device: Senofilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently wearing soft contact lenses Replaces lenses on a weekly or longer schedule Other protocol-defined inclusion/exclusion criteria may apply Exclusion Criteria: Requires concurrent ocular medication Eye injury or surgery within twelve weeks immediately prior to enrollment Currently wearing soft toric lens wearers Those who dispose of their soft lenses on a daily basis Other protocol-defined inclusion/exclusion criteria may apply
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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Senofilcon A / Lotrafilcon A<br>Senofilcon A, followed by Lotrafilcon A | Device: Lotrafilcon A contact lens<br>* Investigational, silicone hydrogel, spherical, soft contact lens<br>Device: Senofilcon A contact lens<br>* Commercially marketed, silicone hydrogel, spherical, soft contact lens<br>|
| Other: Lotrafilcon A / Senofilcon A<br>Lotrafilcon A, followed by Senofilcon A | Device: Lotrafilcon A contact lens<br>* Investigational, silicone hydrogel, spherical, soft contact lens<br>Device: Senofilcon A contact lens<br>* Commercially marketed, silicone hydrogel, spherical, soft contact lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort After Insertion | Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent. | 30-60 seconds after initial insertion |
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to identify work-flow and training implications for introducing this new imaging modality.

Official Title
-----------------
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)

Conditions
-----------------
Barrett's Esophagus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females over the age of 18 years. Patients with either suspected BE presenting for endoscopy or patients with documented BE presenting for follow-up endoscopy likely to require a biopsy or patients presenting for endoscopy for non-BE related conditions other than esophageal varices. Ability to provide written, informed consent. Females who are able to become pregnant, are willing to take a pregnancy test. Exclusion Criteria: Patients on anticoagulation undergoing high risk procedures in accordance to American Society For Gastrointestinal Endoscopy (ASGE) guideline for the management of antithrombotic agents for endoscopic procedures (2009). Patients with esophageal varices that preclude biopsies. Presence of an esophageal mass that precludes full distention of the balloon from the Nvision balloon guide sheath. Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision balloon guide sheath. Patients with known inflammatory disease, esophageal tears or ulcers, which would prohibit full distention of the balloon from the Nvision balloon guide sheath. Patients with known eosinophilic esophagitis. Patients that are pregnant. Patients with a history of hemostasis disorders.

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 |
| --- | --- | --- |
| Primary Effectiveness Endpoint | The primary endpoint will be the number of subjects achieving completed VLE imaging studies at the time of EDG. | The research participants will be followed and evaluated for the duration of their VLE procedure, an expected average of 10 additional minutes beyond the standard EDG procedure. |
Choline Quantification in Breast Cancer by MRS

Study Overview
=================
Brief Summary
-----------------
Choline has been found in increased concentration in breast cancer patients. Hypothesis: The choline signal as observed by MRS is sensitive to treatment, and a positive response to treatment will give a reduction in choline concentration. The purpose of this study is to establish methods for quantification of choline in breast cancer by MRS

Detailed Description
-----------------
Establishment of new MRS sequence for choline quantification of choline. This sequence is choline-selective, and signals from water and lipids are suppressed simultaneously. Compare to different methods for choline quantification. The first method is quantification through an external phantom standard, containing a known concentration of choline. The other method is based on the utilisation of internal water signal as a reference. Both calculations can be performed from the same MR exam. Ten patients will be included in the study.

Official Title
-----------------
Choline Quantification in Breast Cancer by MRS

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: breast cancer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
The Effect of Virtual Reality Glasses on Pain and Anxiety

Study Overview
=================
Brief Summary
-----------------
In recent studies using virtual reality has been proposed as a non pharmacological methods for pain relief but until this time , its effects has not been assessed on pain and anxiety during episiotomy repair. To determine the effectiveness of virtual reality Glasses on pain and anxiety in Primiparity women during episiotomy repair.

Official Title
-----------------
Vice-presidency for Research

Conditions
-----------------
Pain and Anxiety

Intervention / Treatment
-----------------
* Device: Virtual reality glasses and Lidocaine
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Iranian low risk pregnancy Apgar ≥ 7 Exclusion Criteria: vision or ear disorders History of motion sickness or headaches psychological disease or Addiction Prescribe narcotic or sedation 4hour prior to delivery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality glasses and Lidocaine<br>virtual reality glasses and 5 ml Lidocaine 2% | Device: Virtual reality glasses and Lidocaine<br>* The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.<br>|
| Experimental: Lidocaine<br>5 cc Lidocaine2% | Drug: Lidocaine<br>* The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virtual reality glasses decreased pain and anxiety during episiotomy |  | up to 8 months |
The Effect of Carotid IMT (Intima Media Thickness) on Postoperative Cognitive Dysfunction in Patients Undergoing Off-Pump Coronary Artery Bypass Graft Surgery

Study Overview
=================
Brief Summary
-----------------
The patients who have undergone cardiac surgery have higher likelihood of postoperative cognitive dysfunction (POCD). The carotid intima-media thickness (IMT) is associated with cognitive dysfunction in the old. The aim of this study is to evaluate the effect of carotid IMT in patients undergoing OPCAB(off-pump coronary artery bypass surgery) on postoperative cognitive dysfunction. Two hundred twenty four patients, aged 20 to 79 years, scheduled for OPCAB will be divided into increased IMT (n=112) and normal IMT (n=112) group by preoperative B-mode ultrasonography. The cognitive function measured by K-MMSE, MOCA-K before the operation, and on the 7 day, 3 months after operation. The patients in the non-surgical group are measured three times: baseline, after 7days, after 3 months.

Conditions
-----------------
Coronary Artery Occlusive Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients who are scheduled to undergo OPCAB Exclusion Criteria: severe cognitive dysfunction disabling mental change disorder unable to communicate or speak Korean do not have carotid IMT measurement.

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 |
| --- | --- |
| increased carotid IMT group<br>Patients who have increased carotid IMT (intima media thickness) | |
| normal carotid IMT group<br>Patients who have normal carotid IMT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative cognitive dysfunction |  | 7 days after surgery |
Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home

Study Overview
=================
Brief Summary
-----------------
Nowadays, resistance to anti-infectives has become a global public health problem and its increased prevalence threatens human health. To date, few studies have focused on drug compliance in the paediatric population and it varies according to the pathology This drug adherence in the paediatric population is directly linked to outpatient care by the parents or the child's immediate family. In addition, there are no studies on adherence to antibiotics prescribed at the end of hospitalization in the paediatric population. In this context, it seems urgent to seek an intervention capable of leading to responsible and appropriate use of antibiotics in order to improve efficiency in the drug management of acute paediatric infections. This pilot study would characterize pediatric patients and determine the compliance rate in this population.

Official Title
-----------------
Evaluation of the Prevalence of Anti-infective Drug Compliance in Pediatric Patients Hospitalized at Nimes University Hospital After Return Home

Conditions
-----------------
Anti Infective, Pediatric Population

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is under 16 years of age (< 16 years of age). The patient is admitted to a full hospitalization in one of the 2 paediatric units of the University Hospital of Nîmes. The patient is discharged with a prescription for anti-infectives to be taken at home, for a maximum of 30 days. The patient and the holder of parental authority are available for a follow-up of 1 month after discharge from hospital. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |
| Rate of patients observing anti-infectives |  | 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization rates / emergency visits related to worsening infection |  | 2018 |