linjc16/ctgov huggingface dataset:
FU-IFM2009 Database Post IFM/DFCI 2009 Study

Study Overview
=================
Brief Summary
-----------------
Extension of patient follow-up of the IFM/DFCI 2009 study over a period of 4 years (that is, from 01 December 2016 to 30 November 2020) during which patients will be followed up in the normal course of care and according to the usual care of the centers, with collection of the needed data about twice a year by the investigators

Official Title
-----------------
Follow Up-Intergroupe Francophone du Myélome 2009 Database Post IFM/DFCI 2009 Study

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient randomized in the IFM/DFCI 2009 study. Patient still alive must give their non-opposition to the post IFM/DFCI 2009 study data collection until 30 November 2020 Patient non-opposition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| progression free survival | number of deaths | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall long-term survival | number of deaths | 4 years | 
| secondary primary malignancies | number of secondary primary malignancies | 4 years |
Association Between Non-alcoholic Fatty Liver Disease and Iron Status

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease. The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.

Detailed Description
-----------------
Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc. This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).

Official Title
-----------------
(BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)

Conditions
-----------------
NAFLD - Non Alcoholic Fatty Liver Disease

Intervention / Treatment
-----------------
* Procedure: blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 BMI>25 Exclusion Criteria: pregnancy unable to sign an informed consent (legally) known solid/hematological malignancy hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency) active or carrier of viral hepatitis treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, HAART, steroid treatment > 3 months) consumption of > 120g ethanol per week primary liver disease (eg. glycogen storage disease) CRP>20 acute intoxication surgery in previous 7 days

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non alcoholic fatty liver disease<br> | Procedure: blood analysis<br>* A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)<br>|
| control<br> | Procedure: blood analysis<br>* A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade of fatty liver disease |  | 1 year |
A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings

Study Overview
=================
Brief Summary
-----------------
This is a prospective study looking to evaluate whether the treatment outcomes for patients who sustain a distal fingertip amputation are improved or no different when using biological dressings versus artificial dressings.

Official Title
-----------------
A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings

Conditions
-----------------
Finger Injuries, Amputation, Traumatic

Intervention / Treatment
-----------------
* Other: Bacitracin
* Other: Skin Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals presenting at Bellevue Hospital for evaluation and treatment of a finger amputation distal to the germinal matrix that present along with the amputated distal fingertip unit. Exclusion Criteria: replantation candidate, incomplete distal finger-tip amputation

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- |
| Biological Dressings<br>Bacitracin will be applied and covered with xeroform and gauze | Other: Bacitracin<br>* For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.<br>|
| Artificial Dressings<br>the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft | Other: Skin Graft<br>* For the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete healing up to 3 Months |  | 3 months | 
| Percentage of graft viability (for biological dressing only) |  | 1 week | 
| Percentage of graft viability (for biological dressing only) |  | 3 weeks | 
| Percentage of graft viability (for biological dressing only) |  | 6 weeks | 
| Percentage of graft viability (for biological dressing only) |  | 3 months |
Development of Small Airway Disease Questionnaire

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to FEF50% to discriminate between asthmatic patients with and without small airways disease.

Detailed Description
-----------------
Inflammation of the small airways contributes to the severity of the disease and affects the quality of life of patients with asthma. However, the exact role and relevance of small airways disease in asthma is still unclear. This is partly due to the difficulty of measuring small airways pathology with a sensitive and specific parameter. The most commonly used variable as an indicator of small airway obstruction is the FEF50%. Currently, it is not known which clinical symptoms are associated with small airways disease and how a patient will perceive small airway abnormalities. This knowledge is important to assess small airways disease in patients with asthma and adjust therapy to improve quality of life.The primary purpose of this study is to develop a questionnaire for patients with asthma with and without small airways disease for general and specialist practice.

Official Title
-----------------
The Development of a Questionnaire to Assess Symptoms of Small Airways Disease in Patients With Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A doctor diagnosis of asthma Age: ≥ 18 and ≤ 75 years An FEF50% value that is included in either the lowest or the highest 25th percentile. (Percentiles based on the total asthma patient group present from Asthma/COPD service) Exclusion Criteria: Recent exacerbation of asthma (<2 months) or upper respiration tract infection (<2 weeks) Severe airway obstruction at baseline, FEV1pred< 50% or < 1.2L Diagnosis of COPD or another pulmonary disease Pregnancy or lactating women. (i.e. women of childbearing potential who do not use adequate anticonception as judged by the investigator). Restriction, defined as FVC < 80%pred with FEV1/FVC >0.7

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma with small airway disease<br> | |
| Asthma without small airway disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms associated with small airways disease | A questionnaire based on symptoms to discriminate between asthmatic patients with and without small airways disease. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Small airways disease, Questionnaire
Quality of Vision and Quality of Life With LASIK

Study Overview
=================
Brief Summary
-----------------
The investigators are administering a validated questionnaire looking at patient reported quality of life and quality of vision after LASIK surgery

Detailed Description
-----------------
The purpose of the study is to evaluate the prevalence of any functional limitations and their associated factors at one, three, six, and twelve months after LASIK surgery and finally the level of patient satisfaction, including the prevalence of any dissatisfaction and its associated factors at one, three, six and twelve months following LASIK surgery using two questionnaires.

Official Title
-----------------
Patient Quality of Vision and Quality of Life With LASIK Surgery

Conditions
-----------------
Myopia, Astigmatism, Quality of Lifte

Intervention / Treatment
-----------------
* Other: Patient Quality of Life andVision after LASIK Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are aged 21 years or older. Have the ability to give informed consent. Speak and read English fluently. Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery. May benefit from increased spectacle independence. Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations. Have a treatment target of bilateral emmetropia. Express willingness and potential ability to return for all follow-up examinations through the 12-month follow-up exam under the care of the treating investigator. Are not enrolled in any other research study. Exclusion Criteria: Subjects under the age of 21. Patients with excessively thin corneas. Patients with topographic evidence of keratoconus. Patients with ectactic eye disorders. Patients with autoimmune diseases. Patients who are pregnant or nursing.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- |
| Quality of Vision after LASIK surgery<br>Questionnaire | Other: Patient Quality of Life andVision after LASIK Surgery<br>* Patient questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Vision and Quality of Life Questionnaires after LASIK Surgery | Patients will complete questionnaires preoperatively and postoperatively at month twelve. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LASIK, Satisfaction
Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia

Study Overview
=================
Brief Summary
-----------------
Superficial dyspareunia represents a major health problem especially for the newly wed couples. Pulsed radiofrequency for pudendal nerve is a non-neurolytic neuromodulatory method that is effective in relief of this type of pain. Objectives: to evaluate the efficacy of bilateral pudendal nerve fluoroscopic guided pulsed radiofrequency in treatment of intractable non-organic dyspareunia, and compare between trans-gluteal and transvaginal approaches regarding patient comfort and satisfaction.

Official Title
-----------------
Trans-gluteal Versus Trans-vaginal Pudendal Nerve Fluoroscopic Guided Pulsed Radiofrequency for Treatment of Superficial Dyspareunia: a Prospective Cohort Study

Conditions
-----------------
Superficial Dyspareunia

Intervention / Treatment
-----------------
* Procedure: pudendal nerve pulsed radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged between 16 and 46 years and from a near vicinity to our facility to make her available for follow-up Exclusion Criteria: We had excluded women with any abnormality in the transvaginal US guided imagining, or those with any evidence of local gynecological abnormalities on examination. Meanwhile, we had excluded those women with infection at site of injection, coagulopathy or other bleeding diathesis, pre-existing neurologic deficit in the targeted region, those with history of chronic opioid use and women who refused to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 46 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: trans-gluteal approach<br>received pudendal nerve pulsed radiofrequency through trans-gluteal approach | Procedure: pudendal nerve pulsed radiofrequency<br>* received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach<br>|
| Active Comparator: trans-vaginal approach<br>received pudendal nerve pulsed radiofrequency through trans-vaginal approach | Procedure: pudendal nerve pulsed radiofrequency<br>* received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Numerical rating scale | 0 no pain and 10 maximum pain | baseline reading -1 day reading-3 days postoperative reading |
Single Session Pain Education

Study Overview
=================
Brief Summary
-----------------
To pilot single session pain education classes aimed at improving outcomes and behaviors in patients with chronic pain.

Official Title
-----------------
Single Session Pain Education for Chronic Pain

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Single session pain education class


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic pain patients, pain longer than 3 months ability to adhere to and complete study protocols Exclusion Criteria: not fluent in English recent injury at the discretion of the researcher previous completion of pain education class at the discretion of the researcher current cancer diagnosis or other medical condition at the discretion of the researcher

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 |
| --- | --- |
| Experimental: Pain Education<br>Participant will attend a single session pain education course | Behavioral: Single session pain education class<br>* Pain education classes will be provided in person group or virtual settings<br>|
| No Intervention: wait list control<br>Participants will be wait listed then receive intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Tampa scale for kinesiophobia at three months | TSK is a measure of kinesiophobia in people who have chronic pain | month 3 |
Correlation of the Paediatric Tracheal Tube Size

Study Overview
=================
Brief Summary
-----------------
In the context of the study a retrospective data collection of all anaesthesia protocols of children under the age of 12 which underwent surgery in the Charité - University Medicine Berlin, Campus Virchow - Klinikum in the years 2011 and 2012 shall be executed. The correlation of the tracheal tube sizes with the weight, age and height shall be evaluated. This data collection should serve to reevaluate the already published formulas e.g. (Rettberg M. et al., 2011).

Official Title
-----------------
Correlation of the Paediatric Tracheal Tube Size With the Known Formulas for the Calculation of the Size

Conditions
-----------------
Pediatric Tracheal Tube Size

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children under the age of 12 who underwent surgery in the Charité - University Medicine Berlin, Charité Campus Virchow - Klinikum in the years 2011/12 Exclusion Criteria: No endotracheal tube inserted

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 11 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 |
| --- | --- |
| Children under 12 years of age<br>Children under 12 years of age who underwent surgery in the Charité - University Medicine Berlin, Campus Virchow - Klinikum in the years 2011/12 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the tracheal tube size with the known formulas for the calculation of the size. Correlation of the tracheal tube size with the known formulas for the calculation of the size | For many years different weight, height, and/or age-based formulas have been published. The aim of the present study was to identify and to compare published formulas to estimate optimal tube size in pediatric patients. | 24 month data capture |
Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)

Study Overview
=================
Brief Summary
-----------------
This study is an observational study without any hypothesis testing. It intended to observe the clinical application of electrophysiological mapping and catheter ablation of atrial tachycardia post atrial fibrillation ablation or cardiac surgery guided with Rhythmia System.

Official Title
-----------------
Multi-center Complex Atrial Tachycardia High-Resolution Mapping Registry (MATH)

Conditions
-----------------
Atrial Tachycardia (Including Atrial Flutter) Post Atrial Fibrillation Ablation or Cardiac Surgery

Intervention / Treatment
-----------------
* Device: patient who used Rhythmia system and Orion catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with atrial tachycardia (including atrial flutter) post atrial fibrillation ablation or cardiac surgery, which occurred at least 90 days prior to enrollment; Subject is suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion Subject is age 18 or above; Subject or his/ her legal representive understands and is willing to provide the Informed Consent Form (ICF) and participate in this trail. Exclusion Criteria: Subject with atrial fibrillation only; Subject is enrolled in any other concurrent study that might interfere with this study; Women of childbearing potential who are or might be pregnant at the time 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: patient who used Rhythmia system and Orion catheter|suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target patient's type | Type of atrial tachycardia post atrial fibrillation ablation or cardiac surgery. | 1 year |