linjc16/ctgov huggingface dataset:
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Study Overview
=================
Brief Summary
-----------------
A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase. The main purpose is evaluate the safety and efficacy of Nilotinib.

Official Title
-----------------
An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stratum 1: Currently participating in Novartis study CAMN107A2109 Written signed and dated informed consent prior to any study procedures being performed Stratum 2: Male or female > 18 years ECOG 0,1,2 ASL/ALT <= 2.5 ULN or <= 5.0 ULN Alcaline Phosfatase <= 2.5 ULN Serum Bilirrubin <= 1.5 ULN Serum Creatinine <= 1.5 ULN or creatinine clearance >=50 ml/min / 24 hours Serum Lipase <= 1.5 ULN Exclusion Criteria: Stratum 1 and stratum 2: Reduction of the cardiac function Use of Coumadin Other severe medical concurrent conditions Treatment with medications that prolonged the QT interval. Mayor surgery 15 days before the inclusion in the protocol Pregnant women or lactation Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study. |  | between 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response |  | 24 months | 
| To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study |  | 24 months | 
| To follow loss of HR (after previous confirmed HR for AP and CHR for CP) |  | 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Disease,, Resistance,, Intolerance
Evaluation the Effect of Muscle Functional Electrical Stimulation in the Upper Limb Tremor Invalidating

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to identify the superficial muscle groups involved in gene-related tremor and assess the reduction in the intensity of the tremor after transient electrical stimulation.

Conditions
-----------------
Upper Limb Tremor Invalidating

Intervention / Treatment
-----------------
* Other: tremor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with disabling tremor of upper limb Subject with essential tremor action and / or lesion Exclusion Criteria: Subject with drug tremor Subject presenting an exaggerated physiological tremor Subject with isolated resting tremor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: upper limb tremor<br> | Other: tremor<br>* evaluation of the intensity of the tremor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of the intensity of tremor by measuring the hand moving speed (mm / s) |  | at day 0 |
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

Study Overview
=================
Brief Summary
-----------------
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

Detailed Description
-----------------
Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.

Official Title
-----------------
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

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

Intervention / Treatment
-----------------
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable angina in last month indication for percutaneous coronary intervention informed consent Exclusion Criteria: acute coronary syndrome in last 14 days renal insufficiency (creatinine more 150 µmol/l) diseases severely limiting prognosis immunosuppressive treatment statin one month before randomization occlusion of the coronary artery previous participation in this study
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atorvastatin<br>atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) | Drug: Atorvastatin<br>* two days 80mg atorvastatin pre-treatment before PCI<br>* Other names: Torvacard;|
| No Intervention: control<br>PCI without atorvastatin pretreatment | Drug: Atorvastatin<br>* two days 80mg atorvastatin pre-treatment before PCI<br>* Other names: Torvacard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction measured by troponin I level |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural myocardial infarction measured by creatine kinase myocardial band |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, percutaneous coronary intervention, atorvastatin
Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition

Study Overview
=================
Brief Summary
-----------------
The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.

Official Title
-----------------
Prognostic Factors and the Impact of Various Management of Acute Myeloid Leukemia in Real Life Condition at Toulouse and Bordeaux University Hospital

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: intensive chemotherapy
* Drug: Azacitidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with acute myeloid leukemia

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 |
| --- | --- |
| intensive chemotherapy group<br>patients treated with intensive chemotherapy | Drug: intensive chemotherapy<br> <br> |
| Azacitidine group<br>patients treated with azacitidine | Drug: Azacitidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival times | 2 years |
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography

Study Overview
=================
Brief Summary
-----------------
The specific aim of this clinical trial is to translate the investigators new 4DE (three sptial dimensions pluse time) stress echocardiographic method to patients with coronary artery disease referred for clinically indicated dobutamine stress/rest echo to evaluate the reproducibility of the technique in this clinical setting.

Official Title
-----------------
Integrated RF and B-mode Deformation Analysis for 4D Stress Echocardiography

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

Intervention / Treatment
-----------------
* Procedure: Stress Dobutamine Echocardiographic using 4DE System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age, referred for clinically indicated dobutamine rest/stress TTE Provide written informed consent to participate in the study Availability for repease rest/stress TTE within on eweek of clinically indicated study Exclusion Criteria: Unable to give informed consent Unstable hemodynamics that would not allow for repease rest/stress dobutamine transthoracic imaging Recurrent life threatening arrhythmias Heart rate >110 BPM Inadequate windows for transthoracic imagine Patients that have a narrow-angle glaucoma (contraindication for atropine) Change in cardiac medications or management including, coronary revascularization beween intial and repeat TTE study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress Dobutamine Echocardiographic 4DE Image System<br>Subjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system. | Procedure: Stress Dobutamine Echocardiographic using 4DE System<br>* Subjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With an Interpretable 4DE Image | This outcome will measure feasibility. Data from images will be analyzed with the integrated speckle/shape tracking approach (the method uses boundary detection/shape tracking to quantify left ventricular myocardial deformation) | After Stress Echocardiography (Approximately 2 hours) |
The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD

Study Overview
=================
Brief Summary
-----------------
Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.

Official Title
-----------------
The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD

Conditions
-----------------
COPD, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil Citrate
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable for over 1 month mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg never received target therapy before Exclusion Criteria: Patients with other serious respiratory diseases Patients with pulmonary hypertension other than group 3 Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases Patients with limited life expectancy Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months Psychopath or addict Nonstable patients with type Ⅰor Ⅱ respiratory failure Patients with contraindication for sildenafil Patients in pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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
Interventional Model Description: 23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>Sildenafil Citrate, 20mg, tid for 12 weeks | Drug: Sildenafil Citrate<br>* sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events<br>|
| Placebo Comparator: Control group<br>placebo oral tablet, 12 weeks | Drug: Placebo Oral Tablet<br>* placebos treatment for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary artery pressure | pressure in mmHg | 12 weeks | 
| pulmonary vascular resistance | woods | 12 weeks |
Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in Patients Undergoing Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Randomized controlled single blind trial for the evaluation of the treatment of the surgical wound healing process with Platelet-Rich-Fibrin compared to the gold standard (without Platelet-Rich-Fibrin) in patients undergoing knee replacement.

Official Title
-----------------
Effectiveness of Treatment With Rich Platelet Fibrin (PRF) VS Gold Standard in the Healing Process of Surgical Wounds in Patients Undergoing Knee Replacement

Conditions
-----------------
Knee Disease

Intervention / Treatment
-----------------
* Procedure: total knee replacement surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females undergoing a total knee prosthesis. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. Hb > 11 g/dl; Platelet value > 150.000 plt/mmc; Patients with non clinical alteration of ECG; Signature of informed consent; Exclusion Criteria: Patients incapable of understanding and of wanting; Systemic disorders such as diabetes, rheumatic diseases; Patients with malignancy; Thyroid metabolic disorders ; Abuse of alcohol, drugs and pharmaceutical drugs Body mass index > 40;

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>treatment of the surgical wound healing process with Platelet-rich-fibrin in patients undergoing total knee replacement surgery | Procedure: total knee replacement surgery<br>* total knee replacement surgery<br>|
| Active Comparator: B<br>Gold standard treatment of the surgical wound healing process without Platelet-rich-fibrin in patients undergoing total knee replacement surgery | Procedure: total knee replacement surgery<br>* total knee replacement surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement of the healing process | Clinical improvement of the healing process, assessed by application of the Hollander Wound Evaluation Scales at 2 weeks of follow up | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology life quality | Dermatology life quality index improvement at 3 days, 15 days and 1 month | 3 days, 15 days and 1 month |
Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin

Study Overview
=================
Brief Summary
-----------------
Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

Detailed Description
-----------------
The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C. This is a comparative study including two groups of patients randomly allocated : one with paroxetine and the other with the placebo. The rate of depression will be compared between the 2 groups

Official Title
-----------------
Assessment of the Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin. Multicentric, Double-Blinded, Randomized Study. ANRS HC18 Paropeg

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment Exclusion Criteria: Allergy to paroxetine Current antidepressant treatment Depression diagnosed by the MINI International Neuropsychiatric Interview (MINI, DSM IV) History of bipolar syndrome History of psychotic syndrome Treatment by triptan, carbamazepine, millepertuis, methadone, oral anticoagulation Renal insufficiency HIV infection Breath feeding Contra-indication to PEG-interferon and or ribavirin

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of depression score (MADRS and BDI scales) to W74,Quality of life (HQL questionnaire), Fatigue, Compliance to PEG-interferon and ribavirin, Virological response at W74 ,Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Hepatitis C, Paroxetine, Depression