linjc16/ctgov huggingface dataset:
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Official Title
-----------------
An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Conditions
-----------------
Parkinson Disease, Dyskinesia, Drug-Induced, Levodopa

Intervention / Treatment
-----------------
* Drug: AFQ056


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study. Exclusion Criteria: Surgical treatment for PD Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated) Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFQ056<br> | Drug: AFQ056<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). |  | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of dyskinetic symptoms by change from baseline in mAIMS total score |  | 3.5 years | 
| Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively |  | 3.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson Disease, L-dopa, Levodopa, Dyskinesia, involuntary movement, motor complication
Vaccine Exposure in Patients With MS

Study Overview
=================
Brief Summary
-----------------
Vaccines in MS patients have been controversial, in particular hepatitis B vaccine in the 90s and more recently human papillomavirus vaccine. There was an important flu incidence during the winter 2016-2017 that has revealed a low exposure to the flu vaccine in health professionals in France. Vaccine exposure of Multiple sclerosis (MS) patients has not been evaluated yet. Objectives The primary objective is to evaluate exposure to the flu vaccine in patients with MS during the 2016-17 campaign. Secondary objectives are to evaluate exposure to mandatory vaccines, non mandatory vaccines, in the context of immunoactive treatments; to identify potential limitations to vaccines in general in patients with MS. Methods Cross-sectional observational multicentric study, performed in Auvergne-Rhône-Alpes (France). Data will be collected through an auto-questionnaire administered during an out-patient visit or hospitalization, during a two-week period. Statistical analysis Description of the percentage of patients exposed to the flu vaccine, and to other vaccines. Stratification according to demographics (age, sex) and MS related criteria (disability level, relapse in the year before, disease-modifiying drug) Expected results Vaccine exposure of patients with MS will be put in perspective with the general population exposure. The study can provide information regarding potential reluctance of patients with MS towards vaccines. This could lead to develop specific communication tools for patients with MS and/or health professionals.

Official Title
-----------------
Vaccine Exposure in Patients With Multiple Sclerosis in the Auvergne-Rhone-Alpes Region

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Auto-questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Multiple sclerosis according to MacDonald 2010 criteria Age 18 and more Exclusion Criteria: -

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 |
| --- | --- |
| MS patients<br>Single group of patients with MS attending an outpatient MS clinic or hospitalization | Other: Auto-questionnaire<br>* Single Auto-questionnaire administered during or after a consultation/hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients exposed to seasonal flu vaccine in 2016-2017 |  | Two-weeks period in July 2017 |
Exercise and Virtual Reality Exposure Therapy for Acrophobia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether aerobic exercise can enhance the effects of exposure therapy treatment for fear of heights.

Official Title
-----------------
Exercise and Virtual Reality Exposure Therapy for Acrophobia

Conditions
-----------------
Fear of Heights

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 25 Speaks English fluently Score of 80 or higher on the Acrophobia Questionnaire SUDS rating of 50 or higher on the Behavioral Avoidance Test or complete refusal to comply with instructions due to intensity of fear Passes the Physical Activity Readiness Questionnaire-Plus Exclusion Criteria: Hearing or visually impaired Currently receiving exposure-based treatment for acrophobia Able to remain on floor 20 for 30 seconds during BAT with a SUDS rating < 50

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Exercise<br> | |
| Experimental: Exercise Pre<br>30 minutes of aerobic exercise before exposure therapy | Behavioral: Exercise<br>* 30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear scores | Change in fear scores using subjective units of distress will be assessed. | 7 (+/- 3) days after exposure therapy | 
| Perceived threat likelihood scores | Change in the perception of threat likelihood on a scale from 1-5 will be assessed. | 7 (+/- 3) days after exposure therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin conductance fluctuations | Changes in skin conductance fluctuations will be assessed. | 7 (+/- 3) days after exposure therapy | 
| Heart rate fluctuations | Heart rate fluctuations will be assessed. | 7 (+/- 3) days after exposure therapy | 
| Acrophobia Severity | Change in score on the Acrophobia Questionnaire | 14 (+/- 3) days after exposure therapy | 
| Attitudes Toward Heights | Change in score on the Attitudes Toward Heights Inventory | 14 (+/- 3) days after exposure therapy | 
| Clinical Global Improvement | Change in score on the Clinical Global Improvement Scale | 14 (+/- 3) days after exposure therapy |
The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.

Official Title
-----------------
The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Procedure: Computed tomographic scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated withBioresobable Vascular Scaffold for coronary disease Exclusion Criteria: History of allergy to contrast Serum Creatinine > 2.0 mg/dl Severe arrhythmia Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| bioabsorbable scaffold<br>Patients with BVS(bioabsorbable scaffold) for coronary stenosis | Procedure: Computed tomographic scan<br>* after 1year of BVS implantation, computed tomographic scan will be performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computed tomographic scan parameters | Computed tomographic scan parameters predicting clinical outcomes | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis | Restenosis on computed tomographic scan | 1 year | 
| Thrombosis | Thrombosis on computed tomographic scan | 1 year | 
| Lumen loss | lumen loss: the change in minimal lumen diameter on computed tomographic scan | 1 year | 
| Positive predictive value | Positive predictive value on computed tomographic scan | 3 years | 
| Clinical outcomes | Death, target vessel myocardial infarction, clinically driven revascularization | 3 years | 
| Proportion of analyzable lesion | small vessel defined diameter less than 3.0 mm, bifurcation, overlapped lesion | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioabsorbable scaffold, computed tomography
The Use of a Ultra-sound of the Lung to Diagnose Lung Diseases

Study Overview
=================
Brief Summary
-----------------
The study is a prospective open evaluating study of Ultrasound/Doppler application to the chest cavity intended to detect and characterize pathologies of the pulmonary and cardio-vascular system. The system is a noninvasive non-imaging device designated to monitor flow and movement velocity and display the data continuously.

Official Title
-----------------
Detection and Characterization of Cardio-pulmonary Patho-physiological States and Diseases by Ultrasound Transthoracic Doppler

Conditions
-----------------
Pulmonary Pathologies, Cardio-pulmonary Diseases

Intervention / Treatment
-----------------
* Device: ultrasound doppler monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18y or older patients who are clinically suspected of having a significant pulmonary or cardio-pulmonary disease Patients with CHF Patients with pulmonary hypertension Patients with COPD Patients with Asthma Signed informed consent Normal subjects Exclusion Criteria: Patients with unstable conditions: unstable angina, uncontrolled CHF, etc Inability to assume a sitting or supine position Patients with severe chest wall deformity

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 |
| --- | --- |
| pulmonary doppler<br> | Device: ultrasound doppler monitoring<br>* Regular noninvasive chest echo monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnose specific pattern of LDS signals as Power and Velocity in pulmonary diseases in comparison to controls. |  | 1 year |
Does Helipyl Eradicate

Study Overview
=================
Brief Summary
-----------------
Helipyl is on the market; actually it is a post-biotic because it is a killed Lactobacillus reuteri DSMZ 17648. The aim is to demonstrate (or not) that this product eradicates helicobacter, which it claims to do.

Detailed Description
-----------------
This is a pilot project. There is quite limited literature on this product and Helicobacter pylori eradication. My personal opinion is that the literature and guidelines are contradictory. The European guideline is that Helicobacter pylori should not be corrected unless there are serious symptoms . On the other hand, Helicobacter is a carcinogen. Quite often, parents ask us, children's gastroenterologists, to screen their children for Helicobacter because they are symptomatic and are being eradicated, and know that Helicobacter is contagious. This creates a difficult situation: not answering the question is not an option according to the parents' opinion. Going into the question and eradicating classic is against all guidelines. Hence this pilot project: 10 complaints-free carriers of Helicobacter pylori (> 5 years) will be treated with Helipyl for one month (product supplied by the company). Beforehand, at the end of the treatment and a month after stopping of the treatment, we do a C13 breath test.

Official Title
-----------------
Does Helipyl Eradicate

Conditions
-----------------
Eradication

Intervention / Treatment
-----------------
* Other: lactobacillus reuteri DSMZ 17648


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >5 and <18 years male and female asymptomatic helicobacter pylori Exclusion Criteria: helicobacter pylori infection with symptoms <5 years

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: helipyl is given to patients with non symptomatic helicobacter pylori infection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Helipyl<br>helipyl wil be given to 10 children with asymptomatical helicobacter pylori infection | Other: lactobacillus reuteri DSMZ 17648<br>* to evaluate if this product can eradicate helicobacter pylori<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the C13 breathtest | evaluation of C13 breathtest before, at the end of treatment and one month after treatment | 6months |
An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)

Study Overview
=================
Brief Summary
-----------------
An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)

Conditions
-----------------
B-cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged more than18 HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma) Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy Serum ALT no more than 2 x ULN (including normal ALT) Life expectancy 6 months A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause. Informed consent Exclusion Criteria: Other subtype of lymphoma except DLBCL DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months. evidence of hepatocellular carcinoma. evidence of decompensated liver disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Percentage number of patients with hepatitis due to HBV reactivation | Percentage number of patients with hepatitis due to HBV reactivation during the preemptive tenofovir therapy and for 24 weeks after withdrawal from tenofovir. Definition; Hepatitis was defined as a more than 3-fold increase of serum ALT on 2 consecutive determinations at least 5 days apart. Hepatitis was defined to be due to HBV reactivation when it was preceded or accompanied by an increase of serum HBV DNA to more than 10 times that of the pre-exacerbation baseline and the serum HBV DNA turned from negative to positive. | 2 years (every 3 months) | 
| Percentage number of patients with hepatitis due to Safety assessment | Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance | 2 years (every 3 months) | 
| Chemotherapy disruption due to hepatitis | Chemotherapy disruption due to hepatitis: defined as either premature termination or delay of more than 8 days between chemotherapy cycles. | 2 years (every 3 months) |
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Official Title
-----------------
A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

Conditions
-----------------
Relapsing Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: FTY720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age, must have relapsing MS Exclusion Criteria: Patients with a type of MS that is not relapsing Patients with history of chronic immune disease Patients with a history of certain cancers Diabetic patients with certain eye disorders Patients who are on certain immunosuppressive medications or heart medications Patients with certain heart conditions Patients with certain lung conditions Other protocol-defined inclusion/exclusion criteria may apply.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FTY720<br> | Drug: FTY720<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of macular edema |  | 4 months | 
| Incidence of bradyarrhythmic electrocardiograms (ECGs) |  | 4 months | 
| Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing multiple sclerosis, MS, safety, tolerability, health outcomes
Avastin for Post-Photocoagulation Macular Edema

Study Overview
=================
Brief Summary
-----------------
to evaluate the efficacy of a single intravitreal bevacizumab (IVB) injection, 0.1mL (2.5mg), against panretinal photocoagulation (PRP)-induced macular thickening and visual disturbance in patients with severe nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) and good vision

Official Title
-----------------
Prevention of Post-Photocoagulation Macular Edema by Intravitreal Bevacizumab.

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Procedure: Panretinal Photocoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Proliferative retinopathy or severe non-proliferative retinopathy BCVA of 20/63 or better (56 ETDRS letters No history of Macular Edema Central Retinal Thickness of 250mics or more Exclusion Criteria: Previous treatment. Other ophthalmic diseases. history of Nephropathy, heart diseases and pregnancy Media opacities

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Panretinal Photocoagulation + Bevacizumab | Drug: Bevacizumab<br>* Intravitreal administration<br>|
| Experimental: Group 2<br>Panretinal Photocoagulation | Procedure: Panretinal Photocoagulation<br>* Panretinal Photocoagulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Retinal Thickness. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Panretinal Photocoagulation, Macular Edema, Intravitreal Bevacizumab