linjc16/ctgov huggingface dataset:
Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
The cure rate for childhood acute lymphoblastic leukemia (ALL) has increased significantly in recent decades and expected cure rates now exceed 85%. In recent years, Tyrosine Kinase Inhibitor(TKI) has improved outcome of Philadelphia chromosome positive (Ph+)ALL . But in some high risk groups, The prognosis of patients is still very bad and the relapse rate is high. Clearly, new therapies are urgently needed to prevent and /or treat relapsed ALL.

Detailed Description
-----------------
The prognosis of childhood acute lymphoblastic leukemia(ALL) has been increased. Tyrosine Kinase Inhibitor(TKI) has improved Philadelphia chromosome positive (Ph+)ALL treatment outcome. The prognosis of high-risk childhood ALL except for Philadelphia chromosome positive (Ph+)ALL is very bad.

Official Title
-----------------
Philadelphia -Negative High-risk Children Acute Lymphoblastic Leukemia(ALL) Treatment:Induction Therapy:Vincristine(V),Idarubicin(I),L-asparaginase(L),Dexamethasone(D);Consolidation:V+Daunorubicin(D)+L+D, Methotrexate,Cytarabine

Conditions
-----------------
Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome, Ph^1^, Absent, B-cell Childhood Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: Idarubicin(IDA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with high-risk ALL Children lower than 18years old Exclusion Criteria: Bcr/Abl(+) Children with middle-risk or standard-risk ALL

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Idarubicin(IDA)<br>philadelphia negative high -risk ALL : Induction therapy: IDA(6mg/m2/time) one time for each week,altogether 3 times | Drug: Idarubicin(IDA)<br>* 6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.<br>* Other names: darubicin, IDA, Demethoxydaunor Ubicin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The event free survival of high risk ALL |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relapsed rate, death, overall survival |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high risk, Philadelphia Chromosome absent, Childhood acute lymphoblastic leukemia
Assessment of Accelerometric Measurement Devices for Gait Analysis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.

Official Title
-----------------
Assessment of Accelerometric Measurement Devices for Gait Analysis

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Different walk tests with an accelerometer device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy ambulant subject subject affiliated to a social security system subject who signed an informed consent Exclusion Criteria: surgery or recent trauma to the lower limbs (under 6 months) high performance sport chronic treatment alters the strength in the month before inclusion pregnant or nursing woman person under guardianship or curatorship orthopedic, neuromuscular or neurological disease having an impact on the quality of walking

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Different walk tests with an accelerometer device|Subjects will performed three walk tests of 50 meter at different speeds, a six minute walk test, a walking test of 30 seconds then a test to measure the maximum force of extension and knee flexion on each leg. The walk tests will be performed with the accelerometer device (Locometrix) worn in a belt|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometric variables measured for each walk test |  | At baseline | 
| Accelerometric variables measured for each walk test |  | 1 hour after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed measured for each walk test |  | At baseline | 
| Knee flexion and extension strength |  | At baseline | 
| Gait speed measured for each walk test |  | 1 hour after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accelerometer, gait analysis, Healthy subjects
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Study Overview
=================
Brief Summary
-----------------
The primary objective of LUTEGA is it to determine the long term effect (about 1 year) of the supplementation with a fixed combination of lutein/zeaxanthin and omega-3- fatty acids on the optical density (OD) of macular pigment in patients with non- exudative age related maculopathy. Furthermore, it is to be examined whether changes of the optical density are different dosages dependent. Possible changes of lipofuscin content and effect on drusen in AMD patients are studied. The measurement of optical density of macular pigment uses the 1- wavelength reflection method recording reflection images at 460 nm by a fundus camera. The patients are investigated at baseline and are followed up over one year in four more visits. In addition to the OD- measurement each examination includes standardized visual acuity test (ETDRS), amsler- grid, slit lamp biomicroscopy, fundus photography (color and autofluorescence) and a blood sample.

Official Title
-----------------
Long Term Effects of Lutein/Zeaxanthin and Omega-3- Supplementation on Optical Density of AMD Patients (LUTEGA)

Conditions
-----------------
Age Related Maculopathy

Intervention / Treatment
-----------------
* Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA
* Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All non- exudative forms of age related maculopathy Exclusion Criteria: Exudative age related maculopathy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year | Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA<br>* 20mg Lutein, 2mg Zeaxanthin, 510 mg Omega-3-FA; daily supplementation about one year<br>|
| Active Comparator: 2<br>10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year | Dietary Supplement: Lutein/ Zeaxanthin + Omega-3-FA<br>* 10mg Lutein, 1mg Zeaxanthin, 255 mg Omega-3-FA; daily supplementation about one year<br>|
| Placebo Comparator: 3<br>Placebo | Dietary Supplement: Placebo<br>* 0 mg Lutein, Zeaxanthin, Omega-3-FA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical density of macular pigment |  | 12 months |
Validation of a French Quality of Life Questionnaire Adapted to Persons Who Have Suffered a Stroke

Study Overview
=================
Brief Summary
-----------------
The aim of this work is to develop and validate a scale adapted to French cultural characteristics. It will be based on the SS-QoL scale and be simple and quick to use in everyday practice. It is not simply a translation. This transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. The investigators will then develop a short version by reducing the items and conduct a psychometric validation. The translation and validation of a short French version of the SS-QoL scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice. The final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the Dijon Stroke Registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.

Official Title
-----------------
Development and Validation of a French Quality Of Life Scale Specific to Patients Who Have Suffered a Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: completion of a quality of life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years and older. Patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at Dijon CHU and included in the Dijon Stroke Registry cohort. Patients who have provided oral informed consent. Patients with national health insurance cover Exclusion Criteria: History of symptomatic stroke. Meningeal haemorrhage. Severe visual or hearing handicap making it difficult to complete the questionnaire. Global severe aphasia and mutism making communication with the patient impossible-. Unable to read or speak French. Dementia prior to the stroke. Psychiatric disorders and dependence on alcohol/drugs. Bedridden before the stroke. Other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient<br> | Other: completion of a quality of life questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responses to a quality of life questionnaire |  | Change compared with baseline score at Day 15, Day 60 |
The Impact of Lower Limb Fractures on Body Mass Index (BMI)

Study Overview
=================
Brief Summary
-----------------
The study will prospectively follow patients with lower limb fractures to assess changes in weight after injury

Official Title
-----------------
The Impact of Lower Limb Fractures on Body Mass Index (BMI)

Conditions
-----------------
Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with lower limb fractures Exclusion Criteria: Polytrauma Upper limb fractures No consent Lack of follow up Patients opting for weight management treatments Patients with pre-existing mobility status impairment

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of lower limb fractures on body mass index (BMI) | Assessing BMI at different time intervals after lower limb fractures | Change in weight over one year at different time intervals |
Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling

Study Overview
=================
Brief Summary
-----------------
Medication errors are common in intensive care (Valentin A et al., BMJ. 2009;338). Standardized color coded labels for user applied syringes enjoy strong support from many health professionals, thinking that this might increase patient safety. Whether this is true or not warrants further research.

Official Title
-----------------
Questionnaire of the Section Perioperative Intensive Care of the European Society of Intensive Care Medicine (ESICM) on Standardized Drug Labelling

Conditions
-----------------
Drug Labelling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Members of the European Society of Intensive Care Medicine (ESICM)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
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 |
| --- | --- |
| Data collection group: ICU physicians<br>Online survey for ICU physicians (members of the European Society of Intensive Care Medicine (ESICM)). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to assess if standardized drug syringe labelling is used in European ICUs. | Online survey for ICU physicians (members of the ESICM). | A period of 90 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The second objectives is to assess 1. if standards for drug syringe labelling are similar in European ICUs and 2. if users expect that standardized drug syringe labelling should be delivered by the pharmaceutical industry. | Online survey for ICU physicians (members of the ESICM). | A period of 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug labelling, standardized drug syringe labelling, European ICU
Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.

Official Title
-----------------
An Open-label, Long-term, Prospective, Observational Study to Monitor the Safety and Effectiveness of Ilaris in CAPS Patients

Conditions
-----------------
Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS), Muckle-wells Syn (MWS), Neonatal Onset Multisystem Inflam Disease (NOMID)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving Ilaris (canakinumab) at the time of enrollment as part of medical care Exclusion Criteria: Local regulations in some locations may exclude patients who receive Ilaris for a non-approved indication Other protocol-defined inclusion/exclusion criteria may apply
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 monitor and further explore the overall safey of canakinumab focusing in serious infections |  | At least 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term impact of Ilaris on disease progression (including systemic AA amyloidosis as evidenced by renal function, neurologic and ophthalmologic symptoms, and sensorineural deafness) |  | At least 5 years | 
| Growth and development patterns of children aged 4 to 18 years of age exposed to Ilaris |  | at least 5 years | 
| Identify previously unrecognized serious adverse drug reactions in the treated population |  | at least 5 years | 
| Usage and patterns of dosing of Ilaris in routine clinical practice |  | at least 5 years | 
| Incidence of serious infections |  | at least 5 years | 
| Incidence of malignancies |  | at least 5 years | 
| Incidence of hypersensitivity reactions |  | at least 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryopyrin-associated periodic syndromes(CAPS), CIAS1 protein, NLRP3 protein, human cryopyrin protein, Familial Cold Autoinflammatory Syndrome(FCAS), Muckle-Wells Syndrome(MWS), Neonatal Onset Multisystem Inflammatory disease(NOMID), NALP3, canakinumab, Interleukin-1(IL-1)
Effect of Virtual Reality on Dental Patients

Study Overview
=================
Brief Summary
-----------------
Clinicians should appreciate the effectiveness of virtual reality (VR) headsets for managing both the anxiety and the behaviour of dental patients. The aim of this study was to assess the effectiveness of using a VR headset as a distraction for managing the anxiety and behaviour of patients during their dental treatment related to underlying psychological factors.

Official Title
-----------------
Behaviour, Anxiety Management, Personality Traits and Coping of Dental Patients Through Virtual Reality

Conditions
-----------------
Child Behavior Problem, Anxiety, Dental

Intervention / Treatment
-----------------
* Device: virtual reality in dental patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers with dental needs. Children with parental consent Exclusion Criteria: patients with cognitive impairments

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual Reality Group<br>With virtual reality. In order to relate the following variables with the effectiveness in reducing dental anxiety.MDAS TEST (Modified Dental Anxiety Scale) FIS TEST (Facial Imagen Scale) Revised Neo Personality Test (NEO-FFI) Brief Cope Inventory, (coping strategies) | Device: virtual reality in dental patients<br>* The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires<br>|
| Experimental: Control Grooup<br>Without virtual reality. In order to relate the following variables with the effectiveness in reducing dental anxiety.MDAS TEST (Modified Dental Anxiety Scale) FIS TEST (Facial Imagen Scale) Revised Neo Personality Test (NEO-FFI) Brief Cope Inventory, (coping strategies) | Device: virtual reality in dental patients<br>* The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied. Participants self-complete the questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental anxiety | MDAS TEST | 3 years | 
| Behaviour | FIS TEST | 3 years | 
| Personality traits | NEOFFI TEST | 3 years | 
| coping strategies | BRIEF COPE INVENTORY | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, dental anxiety, behaviour, psychological factors
Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in a patients blood and tumor.

Detailed Description
-----------------
Patients on this study are being asked to allow the researchers to take a piece of some normal endometrial tissue and tumor tissue. No additional endometrial tissue will be taken for this study other than what is surgically indicated to resect the patients tumor completely. Prior to this surgery, patients will receive one more dose of L9NC in the outpatient clinic in the same manner as the other L9NC treatments they have received. After the tumor has been removed, the tissue will be examined by a pathologist, who will take what is needed to diagnose the residual disease. What is not needed for patient care will be used for research. A piece of the tumor and some normal endometrial tissue surrounding the tumor will be sent to the Investigational Drug Program laboratory, which is located in the Cancer Center, to measure the amount of drug that is left in the patients tumor. The patients tissue will be kept until all tissues are collected from all patients, which could take up to 10 years. The tissue will not be used for any other purpose. The samples will be labeled with the patients initials.

Official Title
-----------------
1102C-T. Pharmacology Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium. Tissue Submission for Patients With Endometrial Cancer.

Conditions
-----------------
Corpus Uteri, Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients participating in Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients with Metastatic or Recurrent Cancer of the Endometrium are eligible. Exclusion Criteria: Not specified.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrium, Tissue, L9NC